# K993664: Synthetic Vinyl Medical Examination Powdered Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Top Glove Sdn. Bhd.
- Decided: Jan 11, 2000 after 74 days
- Product code: LYZ (Vinyl 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
Synthetic Vinyl Medical Examination Powdered Gloves are worn on the hands of Health care and similar personnel to prevent contamination between health care personnel and the patient.

Source page: https://510kreport.com/device/K993664
Methodology: https://510kreport.com/methodology