# K992210: Shieldmaster Powdered Purple Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Safeskin Corp.
- Decided: Sep 10, 1999 after 71 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.
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) Safeskin blue Nitrile Glove: named in the summary without a submission number

## 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/K992210
Methodology: https://510kreport.com/methodology