# K110146: Nitrile Powder Free Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Tangshan Kaiyue Glove Co., Ltd.
- Decided: May 13, 2011 after 115 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993247 (1999). 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)
- K993247: Nitrile Powder Free Patient Examination Gloves, Jda Intl., Inc. (1999) Summary page 1.

## Recalls of this device
- Apr 1, 2016 · Class II · Z-1828-2016: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non

## Indications for use
Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K110146
Methodology: https://510kreport.com/methodology