# K111134: Non-Sterile, Powder-Free Nitrile Examination Glove, Blue, Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Abbreviated)
- Applicant: Siem Aempemed Corp., Ltd.
- Decided: Jan 26, 2012 after 279 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: 3 generations back to K000323 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080520: Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with Chemotherapy Claim, Siam Sempermed Corp., Ltd. (2008) Summary page 2.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K111134
Methodology: https://510kreport.com/methodology