# K021784: Profeel Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim)

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Jul 24, 2002 after 55 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Class I Powder Free natural rubber latex Surgeon's gloves: named in the summary without a submission number

## Most influential descendants
- K070619: Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling (2007), 0 descendants of its own

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

Source page: https://510kreport.com/device/K021784
Methodology: https://510kreport.com/methodology