# K982600: Profeel Synthetic Copolymer Surgical Gloves (Powdered)

- Pathway: 510(k) (Traditional)
- Applicant: Wembley Rubber Products (M) Sdn Bhd
- Decided: Mar 12, 1999 after 228 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- 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) Elastyren Surgical Glove: named in the summary without a submission number

## Indications for use
The surgeon’s glove is a device made of synthetic copolymer intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K982600
Methodology: https://510kreport.com/methodology