# K993348: Nil, Nitrile Examination Glove - Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Sri Anusham Rubber Industries Pvt., Ltd.
- Decided: Nov 19, 1999 after 45 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) Class I Nitrile Examination Gloves (Powder free) 80LZA: named in the summary without a submission number

## Indications for use
Nitrile Examination Gloves Powder free is a powder free disposable device made of Nitrile Latex intended for medical purpose, that is wom on the examiners hand or finger to prevent contamination between patient and Examiner.

Source page: https://510kreport.com/device/K993348
Methodology: https://510kreport.com/methodology