# K212309: Non-sterile, Powder-Free Latex Examination Glove

- Pathway: 510(k) (Abbreviated)
- Applicant: Sri Trang Gloves (Thailand) Public Company Limited
- Decided: Apr 8, 2022 after 259 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove contains 50 micrograms or less of total water extractable protein per gram. CAUTION: Safe use of this glove by or on latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions

Source page: https://510kreport.com/device/K212309
Methodology: https://510kreport.com/methodology