# K991317: Powder-Free Latex Surgeon's Glove Safeskin PFS Plus Contains 50MLGM or Less of Total Water Extractable Protein Per Gram

- Pathway: 510(k) (Traditional)
- Applicant: Safeskin Corp.
- Decided: May 21, 1999 after 32 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) Safeskin® powder-free latex surgical glove: named in the summary without a submission number

## Indications for use
A surgeon’s glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.

Source page: https://510kreport.com/device/K991317
Methodology: https://510kreport.com/methodology