# K980209: Simplicare Thin Film Wound Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Feb 20, 1998 after 31 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) Innovative Technologies Transparent Thin Film Wound Dressing: named in the summary without a submission number
- (no number) Innovative Technologies Intelligent Thin Film Wound Dressing: named in the summary without a submission number

## Indications for use
The Hollister Thin Film Wound Dressings are intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Thin Film Wound Dressings provide a barrier to bacteria and external contaminates such as urine and feces. The Hollister Thin Film Wound Dressings are also intended to be used on IV sites or as secondary fixation devices for products such as alginates, gels and foam dressings used for venous stasis and diabetic ulcers. OTC: minor burns superficial cuts, lacerations and abrasions minor irritations of the skin Under the care of a health care professional: non-exuding to minimally exuding wounds pressure sores lacerations/abrasions partial and full thickness wounds post-operative surgical wounds second degree burns donor sites IV sites secondary fixation device

Source page: https://510kreport.com/device/K980209
Methodology: https://510kreport.com/methodology