# K032942: Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Dec 17, 2003 after 86 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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 Synthetic rubber latex surgeon's gloves: named in the summary without a submission number

## Most influential descendants
- K222058: Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant (2022), 1 descendant of its own
- K040503: Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural Colour (2004), 1 descendant of its own
- K230578: Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (2023), 0 descendants of its own
- K051562: Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove -  Aloe Vera Coated  Green Colour (2005), 0 descendants of its own

## Indications for use
The surgeon's glove is a device made of synthetic 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/K032942
Methodology: https://510kreport.com/methodology