# K072300: Powder Free Natural Rubber Low Modulus Latex Patient Examination Gloves with a Protein Labeling Claim

- Pathway: 510(k) (Traditional)
- Applicant: Perusahaan Pelindung Getah (M) Sdn Bhd
- Decided: May 16, 2008 after 273 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 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.

Source page: https://510kreport.com/device/K072300
Methodology: https://510kreport.com/methodology