# K081907: Non-Sterile, Powder Free Latex Examination Gloves with  Polymer Coating and Protein Claim  (50 Micrograms or Less)

- Pathway: 510(k) (Abbreviated)
- Applicant: Siam Sempermed Corp., Ltd.
- Decided: Sep 3, 2008 after 62 days
- Product code: LYY (Latex 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: 1 generation back to K970794 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970794: Latex Patient Examination (Powderfree Glove), Siam Sempermed Corp., Ltd. (1997) Summary page 2.

## Indications for use
A patient 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/K081907
Methodology: https://510kreport.com/methodology