# K993452: Green Powdered Latex Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Top Glove Sdn. Bhd.
- Decided: Dec 20, 1999 after 68 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
Powdered Green Latex Examination Gloves (with minimum length of 280mm) are worn on the hands of Health care and similar personnel to give an additional protection until the arm to prevent contamination between health care personnel and the patient especially for the Emergency Medical Service.

Source page: https://510kreport.com/device/K993452
Methodology: https://510kreport.com/methodology