SYLKE® Skin Closure is a single-use, sterile, woven silk fibroin mesh strip coated on one side with a pressure-sensitive adhesive. The adhesive surface is covered by a removable release liner with a pre-slit tab.

Each SYLKE® Skin Closure strip is provided sterile in an individually sealed pouch. The device is available in multiple lengths and widths. Refer to product label and regional catalog for specific dimensions and available packaging configurations.

SYLKE® Skin Closure is a sterile, single-use, silk fibroin mesh strip with a pressure-sensitive adhesive intended for topical skin closure and wound support. The device is used to hold together well-approximated skin edges of a wound, and to cover and protect the wound. The device is designed for wear of up to 14 days. SYLKE® Skin Closure may be applied by healthcare professionals or, where permitted by applicable laws and regulations, by lay users following the included instructions.

SYLKE® Skin Closure is indicated for topical closure and coverage of thoroughly cleansed simple lacerations and minor cuts, where it may be used as the primary skin closure. SYLKE® Skin Closure is also indicated for topical closure and coverage of post-surgical skin incisions in which deeper layers have been closed, where it is used as an adjunct to sutures or staples. Wound edges must be easily approximated without tension.

• SYLKE® Skin Closure is contraindicated for use on infected or contaminated wounds. Signs of infection may include: pus, pain, warmth, redness, swelling, and/or fever. If any signs of infection are present, seek medical attention.
• SYLKE® Skin Closure is contraindicated for use on wounds containing dirt, debris, or other contaminants. Wounds must be thoroughly cleansed prior to application. Trapping contaminants beneath the device may lead to infection.
• SYLKE® Skin Closure is contraindicated for use in high-tension wounds without the support of additional skin closure devices e.g., sutures.
• SYLKE® Skin Closure is contraindicated for use on wounds that are actively bleeding.
• SYLKE® Skin Closure is contraindicated for use below the skin surface.
• SYLKE® Skin Closure is contraindicated for use on mucosal surfaces or surrounding areas including lips, inside the mouth, eyes, eyelids, or the genital and perianal region.

• SYLKE® Skin Closure is intended to be worn for up to 14 days. Early removal of SYLKE® Skin Closure may result in skin stripping, pain, and/or redness. To aid in early removal, SYLKE® Skin Closure may be soaked in warm water to soften the adhesive.
• If signs of infection are present around the wound covered by SYLKE® Skin Closure, contact a medical professional. Do not use SYLKE® Skin Closure if the sterile package is damaged or compromised.
• Individuals with a history of sensitivity to silk or adhesive materials may be at increased risk for skin irritation or allergic reaction. Monitor for signs of hypersensitivity, including redness, swelling, or rash at the application site. If any of these develop, remove the device and contact a healthcare provider.

• Apply SYLKE® Skin Closure only to areas where adhesion can be obtained. Causes of inadequate adhesion include exudate, skin oils, moisture, or areas containing dense hair such as the scalp.
• Performance of SYLKE® Skin Closure under a secondary dressing has not been evaluated. Healthcare providers should use clinical judgment when considering the use of a secondary dressing over SYLKE® Skin Closure. Lay users should not apply a secondary dressing over SYLKE® Skin Closure without first consulting a healthcare provider.
• Submersion in water may impact the device's performance and duration of use.

SYLKE® Skin Closure is not made with natural rubber latex.

SYLKE® Skin Closure has not been evaluated for use in hyperbaric oxygen therapy (HBOT) environments. Safety and performance under hyperbaric conditions have not been established. Healthcare providers should use clinical judgment when considering the use of SYLKE® Skin Closure on patients undergoing HBOT.

For best results, store in a cool, dry place away from direct sunlight. Do not use after the expiration date printed on the label.

SYLKE® Skin Closure is sterilized by ethylene oxide gas. Do not re-sterilize. Do not use if package is opened or damaged. Do not use SYLKE® Skin Closure if strip is damaged or discolored. Discard any unused material.

SYLKE® Skin Closure should only be used on clean, dry wounds when the skin edges of the wound are easily approximated without tension. Examine environment where SYLKE® Skin Closure will be handled and applied and ensure the absence of visible dirt or contaminants.

Step 1. Thoroughly cleanse and dry wound to prepare skin for proper adhesion of SYLKE® Skin Closure to the wound edges. (FIGURE A)

Step 2. Open sterile pouch. Remove SYLKE® Skin Closure strip from pouch. (FIGURE B)

Step 3. With the release liner still in place, hold the strip alongside the wound to measure the required length.The strip should extend at least 1 cm beyond each end of the wound. (FIGURE C)

Step 4. Using clean scissors, trim the strip to the appropriate length. (FIGURE D)

Step 5. Hold the strip and peel back the pre-slit tab to expose the adhesive. (FIGURE E)

Step 6. Place the exposed adhesive section on the skin at least 1 cm beyond one end of the wound. Press firmly to anchor the strip to the skin. (FIGURE F)

Step 7. While holding the anchored end in place, slowly peel away the release liner and press the adhesive strip along the length of the wound. The strip should extend at least 1 cm beyond the opposite end of the wound. If the wound length exceeds the length of a single strip, repeat previous steps with additional devices. (FIGURE G)

Step 8. Press firmly along the entire length of the strip to secure. Check that all edges are flat against the skin and no sections are lifted. Proper adhesion is achieved by applying pressure evenly across the strip. (FIGURE H)

• Do not swim or fully submerge the wound while wearing SYLKE® Skin Closure. Doing so will affect adhesion qualities.
• Keep wound clean and free of dirt and debris. Dirt trapped in the SYLKE® Skin Closure may cause irritation or infection.
• Contact a medical professional if signs of infection or irritation are present.
• Remove SYLKE® Skin Closure after 14 days.
• SYLKE® Skin Closure is not indicated for re-use of the device. The device should be discarded once removed.

Step 1. Gently lift the edge of SYLKE® Skin Closure at one end of the wound.

Step 2. Slowly peel SYLKE® Skin Closure away from the skin along the line of the wound. Use other hand to stabilize the surrounding skin to decrease tension as the SYLKE® Skin Closure strip is peeled off.

Step 3. If SYLKE® Skin Closure does not easily remove from skin, soak strip in warm water to soften adhesive.

Step 4. Once fully removed, discard the skin closure strip in a standard disposal bin. Do not re-use or re-sterilize the device.

Step 5. Any residual adhesive and/or dried wound exudate can be gently cleaned from the skin with warm soapy water. If residue remains, a medical adhesive remover may be used to loosen adhesive remnants.

If you have any questions or comments, please contact SYLKE®, Inc. at info@sylke.com.

Please report a serious incident occurring in relation to the device to SYLKE®, Inc. at quality@sylke.com and the local regulatory authority.

The Instructions for Use are provided in electronic format. If a paper copy is required, it can be requested free of charge, including shipping, via compliance@sylke.com.

SYLKE® Skin Closure is a single-use, sterile, woven silk fibroin mesh strip coated on one side with a pressure-sensitive adhesive. The adhesive surface is covered by a removable release liner with a pre-slit tab.

Each SYLKE® Skin Closure strip is provided sterile in an individually sealed pouch. The device is available in multiple lengths and widths. Refer to product label and regional catalog for specific dimensions and available packaging configurations.

SYLKE® Skin Closure is a sterile, single-use, silk fibroin mesh strip with a pressure-sensitive adhesive intended for topical skin closure and wound support. The device is used to hold together well-approximated skin edges of a wound, and to cover and protect the wound. The device is designed for wear of up to 14 days with routine showering. SYLKE® Skin Closure may be applied by healthcare professionals or, where permitted by applicable laws and regulations, by lay users following the included instructions.

SYLKE® Skin Closure is indicated for topical closure and coverage of thoroughly cleansed simple lacerations and minor cuts, where it may be used as the primary skin closure. SYLKE® Skin Closure is also indicated for topical closure and coverage of post-surgical skin incisions in which deeper layers have been closed, where it is used as an adjunct to sutures or staples. Wound edges must be easily approximated without tension.

• SYLKE® Skin Closure is contraindicated for use on infected or contaminated wounds. Signs of infection may include: pus, pain, warmth, redness, swelling, and/or fever. If any signs of infection are present, seek medical attention.
• SYLKE® Skin Closure is contraindicated for use on wounds containing dirt, debris, or other contaminants. Wounds must be thoroughly cleansed prior to application. Trapping contaminants beneath the device may lead to infection.
• SYLKE® Skin Closure is contraindicated for use in high-tension wounds without the support of additional skin closure devices e.g., sutures.
• SYLKE® Skin Closure is contraindicated for use on wounds that are actively bleeding.
• SYLKE® Skin Closure is contraindicated for use below the skin surface.
• SYLKE® Skin Closure is contraindicated for use on mucosal surfaces or surrounding areas including lips, inside the mouth, eyes, eyelids, or the genital and perianal region.

• SYLKE® Skin Closure is intended to be worn for up to 14 days with routine showering. Early removal of SYLKE® Skin Closure may result in skin stripping, pain, and/or redness. To aid in early removal, SYLKE® Skin Closure may be soaked in warm water to soften the adhesive.
• If signs of infection are present around the wound covered by SYLKE® Skin Closure, contact a medical professional.
• Do not use SYLKE® Skin Closure if the sterile package is damaged or compromised.
• Individuals with a history of sensitivity to silk or adhesive materials may be at increased risk for skin irritation or allergic reaction. Monitor for signs of hypersensitivity, including redness, swelling, or rash at the application site. If any of these develop, remove the device and contact a healthcare provider.

• Apply SYLKE® Skin Closure only to areas where adhesion can be obtained. Causes of inadequate adhesion include exudate, skin oils, moisture, or areas containing dense hair such as the scalp.
• Performance of SYLKE® Skin Closure under a secondary dressing has not been evaluated. Healthcare providers should use clinical judgment when considering the use of a secondary dressing over SYLKE® Skin Closure. Lay users should not apply a secondary dressing over SYLKE® Skin Closure without first consulting a healthcare provider.
• Submersion in water may impact the device's performance and duration of use.

SYLKE® Skin Closure is not made with natural rubber latex.

SYLKE® Skin Closure has not been evaluated for use in hyperbaric oxygen therapy (HBOT) environments. Safety and performance under hyperbaric conditions have not been established. Healthcare providers should use clinical judgment when considering the use of SYLKE® Skin Closure on patients undergoing HBOT.

SYLKE® Skin Closure is MR Safe. The device is composed entirely of non-metallic, non-magnetic, non-electrically conductive materials. Non-clinical testing demonstrated that it poses no known hazards in all MR environments and does not need to be removed prior to magnetic resonance imaging.

For best results, store in a cool, dry place away from direct sunlight. Do not use after the expiration date printed on the label.

SYLKE® Skin Closure is sterilized by ethylene oxide gas. Do not re-sterilize. Do not use if package is opened or damaged. Do not use SYLKE® Skin Closure if strip is damaged or discolored. Discard any unused material.

SYLKE® Skin Closure should only be used on clean, dry wounds where the skin edges of the wound are easily approximated without tension. Examine environment where SYLKE® Skin Closure will be handled and applied. Ensure the absence of visible dirt or contaminants.

Step 1. Thoroughly cleanse and dry wound to prepare skin for proper adhesion of SYLKE® Skin Closure to the wound edges.

Step 2. Open sterile pouch. Remove SYLKE® Skin Closure strip from pouch.

Step 3. With the release liner still in place, hold the strip alongside the wound to measure the required length. The strip should extend at least 1 cm beyond each end of the wound.

Step 4. Using clean scissors, trim the strip to the appropriate length.

Step 5. Hold the strip and peel back the pre-slit tab to expose the adhesive.

Step 6. Place the exposed adhesive section on the skin at least 1 cm beyond one end of the wound. Press firmly to anchor the strip to the skin.

Step 7. While holding the anchored end in place, slowly peel away the release liner and press the adhesive strip along the length of the wound. The strip should extend at least 1 cm beyond the opposite end of the wound. If the wound length exceeds the length of a single strip, repeat previous steps with additional devices.

Step 8. Press firmly along the entire length of the strip to secure. Check that all edges are flat against the skin and no sections are lifted. Proper adhesion is achieved by applying pressure evenly across the strip.

• SYLKE® Skin Closure is designed to be worn for up to 14 days with routine showering.
• When showering, do not scrub the device with a loofah, exfoliant, or other abrasive. Gently pat dry.
• Do not swim or fully submerge the wound while wearing SYLKE® Skin Closure.
• Keep wound clean and free of dirt and debris. Dirt trapped in the SYLKE® Skin Closure may cause irritation or infection.
• Contact a healthcare provider if the device detaches partially or completely before 14 days or if signs of infection or irritation are present.
• Remove SYLKE® Skin Closure after 14 days.
• SYLKE® Skin Closure is a single-use device and must not be reapplied after removal.

Step 1. Gently lift the edge of SYLKE® Skin Closure at one end of the wound.

Step 2. Slowly peel SYLKE® Skin Closure away from the skin along the line of the wound. Use other hand to stabilize the surrounding skin to decrease tension as the SYLKE® Skin Closure strip is peeled off.

Step 3. If SYLKE® Skin Closure does not easily remove from skin, soak strip in warm water to soften adhesive.

Step 4. Once fully removed, discard the skin closure strip in a standard disposal bin. Do not re-use or re-sterilize the device.

Step 5. Any residual adhesive and/or dried wound exudate can be gently cleaned from the skin with warm soapy water. If residue remains, a medical adhesive remover may be used to loosen adhesive remnants.

If you have any questions or comments, please contact SYLKE®, Inc. at info@sylke.com.

Please report a serious incident occurring in relation to the device to SYLKE®, Inc. at quality@sylke.com and the local regulatory authority.

The Instructions for Use are provided in electronic format. If a paper copy is required, it can be requested free of charge, including shipping, via compliance@sylke.com.

Legal Manufacturer

SYLKE, Inc.

4150 Regents Park Row, Suite 300

La Jolla, CA 92037

United States

858-727-9553 · info@sylke.com

EU Authorized Representative

Emergo Europe

Westervoortsedijk 60, 6827 AT, Arnhem, The Netherlands

+31 70.345.8570

SRN: NL-AR-000000116

EU Importer

MedEnvoy Global B.V.

Prinses Margrietplantsoen 33, Suite 123

2595 AM The Hague, The Netherlands

Switzerland Authorized Representative & Importer

MedEnvoy Switzerland

Gotthardstrasse 28, 6302 Zug, Switzerland

UKRP & UK Importer

MedEnvoy UK Limited

167-169 Great Portland Street, 5th Floor

London, W1W 5PF, United Kingdom

The downloadable IFU includes English, Arabic, Chinese (Simplified), Czech, Danish, Dutch, Finnish, French (Canada), French (France), German, Greek, Hungarian, Italian, Japanese, Korean, Polish, Portuguese (Brazil), Portuguese (Portugal), Romanian, Slovak, Spanish (Latin America), Spanish (Spain), Swedish, Turkish, and Vietnamese.

A paper copy of the Instructions for Use is included in every box of SYLKE® Skin Closure. This page provides the same Instructions for Use in electronic form for reference.

Current version: SYL-LB-4039 Rev. B. Previous versions are available on request from compliance@sylke.com.

Additional paper copies can be requested free of charge, including shipping, via compliance@sylke.com.

SYLKE® Adhesive Wound Closure is a single use, sterile, woven silk mesh coated with a long lasting, pressure sensitive adhesive.

Each sterile wound closure is provided in an individually packaged pouch, with a liner covering the adhesive until the wound closure is ready for use. Each wound closure is provided as a 2.5cm by 32cm, 2.5cm by 16cm, 3.4cm by 24cm strip, allowing use on a variety of wound lengths and for any excess to be trimmed away.

SYLKE® Adhesive Wound Closure is a sterile, single-use silk mesh strip with pressure sensitive adhesive intended to approximate and secure the edges of clean, superficial skin wounds (e.g. simple lacerations, cuts, puncture wounds post-surgical incisions.). It provides a breathable, sterile barrier that supports natural healing. The strip can be used alone or with sutures, may be applied by consumers or healthcare professionals in home or clinical settings, and is designed to remain in place for up to 14 days while tolerating normal bathing.

SYLKE® Adhesive Wound Closure is indicated for topical closure and coverage of thoroughly cleansed simple lacerations, cuts, puncture wounds, and post-surgical skin incisions (including those with subcutaneous or dermal sutures), to assist in bringing together skin edges and protecting the wound during the initial healing period.

• SYLKE® Adhesive Wound Closure is contraindicated for use on infected wounds. Signs of infection may include: pus, pain, warmth, redness, swelling, and/or fever. If any signs of infection are present, seek medical attention.
• SYLKE® Adhesive Wound Closure is contraindicated for use on dirty wounds. Wounds must be thoroughly cleansed and free of dirt, debris, and any foreign objects prior to application.
• SYLKE® Adhesive Wound Closure is contraindicated for use in high-tension wounds without the support of additional skin closure devices i.e. sutures.
• SYLKE® Adhesive Wound Closure is contraindicated for use on wounds that are actively bleeding.

• Do not use SYLKE® Adhesive Wound Closure on areas where adhesion cannot be obtained. Potential causes of inadequate adhesion are presence of exudate, skin oils, moisture, or areas containing dense hair such as the scalp.
• Do not use SYLKE® Adhesive Wound Closure on mucosal surfaces including lips or inside the mouth.
• Do not use SYLKE® Adhesive Wound Closure near the eye or over eyelids.
• Do not use SYLKE® Adhesive Wound Closure on intimate areas.
• SYLKE® Adhesive Wound Closure is made with a long-lasting adhesive and is intended to be worn for two weeks with regular bathing. Early removal of SYLKE® Adhesive Wound Closure may result in skin stripping, pain, and/or redness. SYLKE® Adhesive Wound Closure may be soaked in warm soapy water to soften the adhesive and aid in early removal.
• If signs of infection are present around the wound covered by SYLKE® Adhesive Wound Closure, contact a medical professional.
• SYLKE® Adhesive Wound Closure should not be used below the skin surface.
• Do not use SYLKE® Adhesive Wound Closure if the sterile package is damaged or compromised.
• Do not swim or otherwise immerse the wound in water for prolonged periods. Immersing the SYLKE® Adhesive Wound Closure in water may cause the bandage to lose adhesiveness resulting in early detachment.

Recommended storage conditions: below 30°C (86°F), away from moisture, direct heat, and direct light. Do not use after expiration date.

SYLKE® Adhesive Wound Closure is sterilized by ethylene oxide gas. Do not resterilize. Do not use if package is opened or damaged. Do not use if SYLKE® Adhesive Wound Closure strip is damaged or discolored. Discard any unused material.

SYLKE® Adhesive Wound Closure should only be used on clean, dry wounds when the skin edges of the wound are closely positioned without effort. Examine environment where SYLKE® Adhesive Wound Closure will be handled and applied and ensure the absence of visible dirt or contaminants.

Step 1. Thoroughly cleanse and dry wound to prepare skin for proper adhesion SYLKE® Adhesive Wound Closure to the wound edges.

Step 2. Open sterile pouch. Remove SYLKE® Adhesive Wound Closure strip from pouch.

Step 3. Grasp strip and remove pre-slit 1.5” tab to expose adhesive layer.

Step 4. Position adhesive portion at least 1 cm over the end of the wound and press gently to ensure full adhesion to skin.

Step 5. Remove liner while pressing adhesive strip over length of wound until at least 1 cm of SYLKE® Adhesive Wound Closure extends over the edge of the wound. If length of the wound exceeds length of SYLKE® Adhesive Wound Closure, repeat previous steps with additional devices.

Step 6. Trim excess dressing with clean scissors.

Step 7. Press gently along entire strip to secure. Proper adhesion is achieved by applying pressure evenly across the strip.

• Do not swim or fully submerge the wound while wearing SYLKE® Adhesive Wound Closure. Doing so will affect adhesion qualities.
• Keep wound clean and free of dirt and debris. Dirt trapped in the SYLKE® Adhesive Wound Closure may cause irritation or infection.
• Contact a medical professional if signs of infection or irritation are present.
• Remove SYLKE® Adhesive Wound Closure after 14 days.
• SYLKE® Adhesive Wound Closure is not indicated for re-use of the device. The device should be discarded once removed.

Step 1. Gently lift the edge of SYLKE® Adhesive Wound Closure at one end of the wound.

Step 2. Slowly peel SYLKE® Adhesive Wound Closure away from skin along the line of the wound. Use other hand to stabilize the wound to decrease tension as the SYLKE® Adhesive Wound Closure strip is peeled off.

Step 3. If SYLKE® Adhesive Wound Closure does not easily remove from skin, soak strip in warm water to soften adhesive.

Step 4. Once fully removed, discard the used wound closure. Do not reuse or resterilize the device.

Step 5. Any residual adhesive and/or dried wound exudate can be gently cleaned from the skin with warm soapy water. If residue remains, an alcohol pad may be used to loosen adhesive remnants.

In the event of a serious incident, such as an adverse reaction or complication, the physician or user should reach out to SYLKE®, Inc. by emailing quality@sylke.com.

ANVISA No.: 80117589143

Israeli Registration Holder

I.L. Emergo Israel Ltd.

9 Andrei Sakharov St., Matam

P.O.B. 15401

Haifa 3190501

Legal Manufacturer: SYLKE, Inc.

AMAR Registration Number: 24820324

Malaysia Registration Holder

Edaran Bio-Medik SDN BHD

Unit 8-7-5, Menara Mutiara Bangsar

Jalan Liku, 59100 Bangsar

Selangor Darul Ehsan

Legal Manufacturer: SYLKE, Inc.

MDA Registration Number: GA3992625-200615

Australia Sponsor

Emergo Australia

Level 20 Tower II

201 Sussex Street

Sydney, NSW 2000

Australia

Manufacturer

SYLKE, Inc.

4150 Regents Park Row

Suite 300

La Jolla, CA 92037, USA

858-72-SYLKE

info@sylke.com

www.sylke.com