# K021992: DHS Disposable Hood System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 14, 2003 after 210 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) Stryker Steri-Shield Personal Protection Device: named in the summary without a submission number
- (no number) DePuy Sterile View Disposable Hood / Gown: named in the summary without a submission number

## Indications for use
The device is a sterile, single-use, personal protective system designed to provide a barrier between the surgical team and potentially hazardous bloodborne pathogens that may be present in the operation room environment. The device also offers the patient additional protection from potential deep wound infection by preventing skin, hair and other debris entry into the wound from surgical team members

Source page: https://510kreport.com/device/K021992
Methodology: https://510kreport.com/methodology