# K122363: Non-Sterile, Powder Free Nitrile Examination Gloves, Blue

- Pathway: 510(k) (Abbreviated)
- Applicant: Siam Sempermed Corp., Ltd.
- Decided: Sep 10, 2012 after 35 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: 4 generations back to K000323 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083755: Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color, Polymer Coated, Texted with Chemotherapy Drugs, Siam Sempermed Corp., Ltd. (2009) Summary page 2.

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

Source page: https://510kreport.com/device/K122363
Methodology: https://510kreport.com/methodology