# K971945: Pure Advantage Powder Free Nitrile Hypoallergenic Surgical Glove

- Pathway: 510(k) (Traditional)
- Applicant: Tillotson Healthcare Corp.
- Decided: Jul 14, 1997 after 48 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
Longest line of descent: 1 generation back to K922116 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922116: Powder Free Nitrile Glove, Hpi, Inc. (1993) Summary page 1.

## Indications for use
The Pure Advantage Powder Free Nitrile Surgical Glove, Hypoallergenic is "a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination"

Source page: https://510kreport.com/device/K971945
Methodology: https://510kreport.com/methodology