# K121526: Power-Free Nitrile Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Junchi Medical Products Co., Ltd.
- Decided: Aug 3, 2012 after 72 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 K993247 (1999). 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)
- K082598: Powder Free Blue Patient Nitrile Examination Glove, Tangshan Zhonghong Pulin Group Co., Ltd. (2009) Summary page 1.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21 CFR 880.6250)

Source page: https://510kreport.com/device/K121526
Methodology: https://510kreport.com/methodology