# K123488: Linshi Nitrile Disposable Exam Gloves, Powder-Free

- Pathway: 510(k) (Traditional)
- Applicant: Puyang Linshi Health Co., Ltd.
- Decided: Feb 8, 2013 after 87 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 K062764 (2007). 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)
- K121947: Ets Blue Powder-Free Patient Nitrile Examination Gloves, Northstar Healthcare Holdings (2012) Summary page 1.

## Indications for use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examinees hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K123488
Methodology: https://510kreport.com/methodology