# K992358: Correct Touch Powder Free 911 Latex Examination Gloves, (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Biopro (M) Sdn Bhd
- Decided: Sep 10, 1999 after 58 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
The Powder Free 911 Latex Examination gloves is disposable device mmtended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K992358
Methodology: https://510kreport.com/methodology