Device Dossier
Adhesive strip, skin-closure
Device Dossier for Adhesive strip, skin-closure (Adhesive strip, skin-closure, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN category —…
- GMDN category: Adhesive strip, skin-closure
Intended purpose
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.