# K970794: Latex Patient Examination (Powderfree Glove)

- Pathway: 510(k) (Traditional)
- Applicant: Siam Sempermed Corp., Ltd.
- Decided: May 6, 1997 after 63 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
No predicates in its family tree.
8 later devices descend from it; 5 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K024121: Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating,  Aloe, Vitamin E and Protein Claim (2002), 2 descendants of its own
- K121549: Non-Sterile, Powder-Free Nitrile Examination Glove, Blue (2012), 1 descendant of its own
- K100907: Non-Sterile, Powder Free Latex Examination Gloves and Protein Claim (50 Micrograms or Less) Model: White: X-Small, Small (2010), 1 descendant of its own
- K142685: Nitrile Examination Gloves with Aloe & Vitamin E, Powder- Free (2015), 0 descendants of its own
- K111133: Non-Sterile, Powder Free Latex Examination Gloves with Protein Claim (50 MG or Less) (2011), 0 descendants of its own

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

Source page: https://510kreport.com/device/K970794
Methodology: https://510kreport.com/methodology