# K090066: Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling Claim of 50 Micrograms Per DM2 of Glove

- Pathway: 510(k) (Traditional)
- Applicant: Wear Safe (Malaysia) Sdn. Bhd.
- Decided: May 15, 2009 after 126 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- 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
A powder free polymer coated latex surgical glove is a disposable device made of natural rubber material intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K090066
Methodology: https://510kreport.com/methodology