# K962139: Safeskin

- Pathway: 510(k) (Traditional)
- Applicant: Safeskin Corp.
- Decided: Dec 19, 1996 after 199 days
- Product code: LZA (Polymer Patient Examination Glove)
- 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 K932404 (1994). 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)
- K932404: Nitrile Rubber Powder-Free Examination Glove, Safeskin Corp. (1994) Summary page 2.

## Indications for use
A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient’s body, fluids, waste or environment.

Source page: https://510kreport.com/device/K962139
Methodology: https://510kreport.com/methodology