# K992436: Gown Back, Model 13-403N; 13-404N; 13-405N

- Pathway: 510(k) (Traditional)
- Applicant: Techstyles
- Decided: Jan 20, 2000 after 182 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) Optima® Surgical Gowns: named in the summary without a submission number
- (no number) Orex Surgeon’s Vest: named in the summary without a submission number
- (no number) White Knight Surgeon’s Vest: named in the summary without a submission number

## Indications for use
Target population: Surgeons or other members of the surgical team. The Gown Back is to be worn over a surgeon’s gown during procedures and in situations when the surgeon’s back needs to be considered sterile. This accessory device is used protect both operating room personnel and the surgical patient from the transfer of microorganisms, body fluids, and particulate matter.

Source page: https://510kreport.com/device/K992436
Methodology: https://510kreport.com/methodology