# K961239: Depuy Sterile View Barrier Hood/Gown with Hytrel

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Sep 17, 1996 after 169 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- 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) DePuy Sterile View Barrier Hood/Gown UV: named in the summary without a submission number
- (no number) Stackhouse Freedom Mark III Surgical Helmet System: named in the summary without a submission number
- (no number) Baxter Converters Breathable Gown: named in the summary without a submission number

## Indications for use
The Sterile View Barrier Hood/Gown with Hytrel is intended as disposable surgical apparel to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K961239
Methodology: https://510kreport.com/methodology