# K211667: Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Universal Medical Equipment Co., Ltd.
- Decided: Sep 23, 2021 after 114 days
- Product code: LAZ (N-Acetylprocainamide Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K022765 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102593: Synthetic, Powder-Free Nitrile Examination, Zibo Yinghao Medical Products Co., Ltd. (2010) Summary page 4.

## Indications for use
Disposable Medical Synthetic Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K211667
Methodology: https://510kreport.com/methodology