# K992830: Safeskin Polymer-Coated Nitrile Examination Gloves, Powder-Free Shieldmaster Nitrile Glove

- Pathway: 510(k) (Traditional)
- Applicant: Safeskin Corp.
- Decided: Oct 27, 1999 after 65 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 blue nitrile examination glove: named in the summary without a submission number

## Most influential descendants
- K131841: Kimberly-Clark Lavender Nitrile Powder-Free Exam Glove (2013), 0 descendants of its own

## Indications for use
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.

Source page: https://510kreport.com/device/K992830
Methodology: https://510kreport.com/methodology