# K970135: Nitrile Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Sage Products, Inc.
- Decided: Aug 25, 1997 after 222 days
- Product code: LZC (Medical Glove, Specialty)
- Device class: 1
- Regulation: 21 CFR 880.6250
- 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 K902696 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902696: N-DEX, Moss Point Glove Co. (1990) Summary page 2.
- K915086: Hpi Brown Nitrile Sensi-Grip Surgical Gloves, Hpi, Inc. (1992) Summary page 2.
- (no number) Safeskin Gloves: named in the summary without a submission number
- (no number) Nitrex: named in the summary without a submission number
- (no number) N-Dex 8005: named in the summary without a submission number

## Indications for use
A medical glove worn on the hand of a healthcare worker and similar personnel to prevent contamination between healthcare personnel and patient. In addition, this glove is worn for the protection of the wearer against exposure to chemotherapeutic agents.

Source page: https://510kreport.com/device/K970135
Methodology: https://510kreport.com/methodology