# K965005: Iamin Impregnated Gauze Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Procyte Corp.
- Decided: Feb 24, 1997 after 70 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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) Dermagran Wound Dressing: named in the summary without a submission number
- (no number) SteriCare Hydrogel Gauze Dressing: named in the summary without a submission number
- (no number) CarraGauze Hydrogel Wound Dressing: named in the summary without a submission number
- (no number) lamin Hydrating Gel: named in the summary without a submission number

## Indications for use
An impregnated hydrogel for the dressing and management lamin Impregnated Gauze Dressing is intended to be used for the dressing and management of pressure ulcers (stage |-1V), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient’s skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and contamination.

Source page: https://510kreport.com/device/K965005
Methodology: https://510kreport.com/methodology