# K021855: Top Glove Powderfree Latex Examination Glove with Protein Labelling Claims (50 Micrograms or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Top Glove Sdn. Bhd.
- Decided: Aug 5, 2002 after 60 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
Latex examination powderfree 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/K021855
Methodology: https://510kreport.com/methodology