# K020019: Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim)

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Jan 23, 2002 after 20 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: 1 (0 Class I)
- 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
- K232079: Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (2024), 0 descendants of its own

## Recalls of this device
- May 7, 2018 · Class II · Z-2036-2018: Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in sensitizatio

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

Source page: https://510kreport.com/device/K020019
Methodology: https://510kreport.com/methodology