# K993805: Nitri-Care Nitrile Powder-Free Sterile Medical Examination Gloves (Blue, Cherry Flavored)

- Pathway: 510(k) (Traditional)
- Applicant: Best Manufacturing Company
- Decided: Mar 10, 2000 after 122 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: 2 generations back to K902696 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992170: N-Dex Blue Powder-Free Nitrile Medical Examination Glove, Best Manufacturing Company (1999) Summary page 1.

## Indications for use
The NITRI-CARE Nitrile Powder-Free Sterile Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).

Source page: https://510kreport.com/device/K993805
Methodology: https://510kreport.com/methodology