# K992302: Dermaphylyx Skin Protectors, Protect IT Skin Protectors

- Pathway: 510(k) (Traditional)
- Applicant: Dermaphylyx, Inc.
- Decided: Sep 14, 1999 after 68 days
- Product code: MGP (Dressing, Wound And Burn, Occlusive)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Spyroflex® Skin Protectors: named in the summary without a submission number

## Indications for use
Dermaphylyx Skin Protectors act like an extra layer of skin. They are intended to be used in the prevention of blisters and friction burns. The following indications for use are for Prescription and Over-the-Counter Use: Dermaphylyx Skin Protectors are intended for the prevention of: Blisters Friction Burns

Source page: https://510kreport.com/device/K992302
Methodology: https://510kreport.com/methodology