# K021119: Powdered Brown Latex Surgical Gloves, Sterile with Expiration Date Labeling Claim & Protein Content Labeling Claim

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Jul 5, 2002 after 88 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
Longest line of descent: 1 generation back to K960416 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960416: Comfit Microptic, Wembley Rubber Products (M) Sdn Bhd (1996) Summary page 1.

## Indications for use
The surgical glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K021119
Methodology: https://510kreport.com/methodology