# K971381: Powder-Free Duraprene Sterile Synthetic Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Jul 9, 1997 after 86 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) Powdered Duraprene™ Surgical Gloves: named in the summary without a submission number

## Indications for use
These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as non-invasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K971381
Methodology: https://510kreport.com/methodology