# K961341: Convertors Polyolefin Fabric Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Oct 28, 1996 after 203 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) Convertors® SMS Polyolefin Standard Gown: named in the summary without a submission number
- (no number) Convertors® SMS Polyethylene standard gown: named in the summary without a submission number
- (no number) Kimberly-Clark standard gown: named in the summary without a submission number
- (no number) Kimberly-Clark fabric-reinforced gown: named in the summary without a submission number
- (no number) Kimberly-Clark poly-reinforced gown: named in the summary without a submission number

## Indications for use
Surgical apparel are devices intended 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/K961341
Methodology: https://510kreport.com/methodology