# K093517: Nitritech or Multiple Private Label Non-Sterile Powder Free Nitrile Patient Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Summit Glove, Inc.
- Decided: Jun 29, 2010 after 228 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 K090828 (2009). 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)
- K090828: Non-Sterile, Powder Free Nitrile Examination Gloves, Ultrawin Sdn Bhd (2009) Summary page 1.

## Indications for use
The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.

Source page: https://510kreport.com/device/K093517
Methodology: https://510kreport.com/methodology