# K962666: Bemiss Jason-Sterile,Non-Sterile,Reinforced Sterile,and Reinforced Non-Sterile Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Bemiss-Jason Corp., Triad Medical Div.
- Decided: Feb 27, 1997 after 233 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) Isolyser (Mars White Knight) surgical gowns: named in the summary without a submission number

## Indications for use
Disposable / Single Use Only Surgical apparel worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel.

Source page: https://510kreport.com/device/K962666
Methodology: https://510kreport.com/methodology