# K121549: Non-Sterile, Powder-Free Nitrile Examination Glove, Blue

- Pathway: 510(k) (Abbreviated)
- Applicant: Siam Sempermed Corp., Ltd.
- Decided: Dec 27, 2012 after 216 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). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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.
- K024121: Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating,  Aloe, Vitamin E and Protein Claim, Siam Sempermed Corp., Ltd. (2002) Summary page 2.

## Most influential descendants
- K142685: Nitrile Examination Gloves with Aloe & Vitamin E, Powder- Free (2015), 0 descendants of its own

## Indications for use
This is a medical device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K121549
Methodology: https://510kreport.com/methodology