# K153678: PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove

- Pathway: 510(k) (Traditional)
- Applicant: Permeaderm, Inc.
- Decided: Aug 8, 2016 after 231 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K082869 (2009). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091863: Awbat-S Plus, Awbat-D Plus, Awbat-M Plus, Aubrey, Inc. (2010) Summary page 4.
- K790496: Biobrane Brand Temporary Wound Dressing, Woodroof Laboratories, Inc. (1979) Summary page 4.
- K061711: Oasis Wound Matrix, Cook Biotech, Inc. (2006) Summary page 4.

## Most influential descendants
- K212579: FortiShield (Biosynthetic Wound Matrix) (2023), 0 descendants of its own

## Indications for use
PermeaDerm B, CW and Glove are intended for use as wound coverings and to provide a moist wound healing environment on cleanly debrided wounds after hemostasis has been established. PermeaDerm B is indicated for partial thickness burn wounds, donor sites and coverage of meshed autograft. PermeaDerm CW is indicated for partial thickness wounds, pressure sores, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh’s, post-laser surgery, podiatric, wound dehiscence, trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. PermeaDerm Glove is indicated for debrided partial thickness hand burns.

Source page: https://510kreport.com/device/K153678
Methodology: https://510kreport.com/methodology