# K994201: Rubbercare Powder-Free, Guardian Powder-Free Latex Exam Gloves with Protein Labeling Claim (50 Micrograms or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Perusahaan Pelindung Getah (M) Sdn Bhd
- Decided: Feb 7, 2000 after 56 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. The FDA summary names no predicate by number.

## Indications for use
The device is intended as a protective device to be worn on the hands of healthcare or similar personnel to prevent cross-contamination between the wearer and the person being examined. It may also be used in similar context during the handling of body fluids such as whole blood and plasma to protect the users from any risks of infections.

Source page: https://510kreport.com/device/K994201
Methodology: https://510kreport.com/methodology