PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)

• K Number: K021784
• Device Name: PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
• Manufacturer: WRP ASIA PACIFIC SDN. BHD.
• Date Cleared: 2002-07-24 ( 55 days)
• Product Code: KGO
• Regulation Number: 878.4460
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: K070619

Intended 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.

Device Description

The Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577-0151 and FDA 21 CFR 800.20.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Standards)	Reported Device Performance
Dimensions	ASTM D 3577 - 01E1	Meets
Physical Properties	ASTM D 3577 - 01E1	Meets
Freedom from pinholes	ASTM D 3577 - 01E1; FDA 21 CFR 800.20	Meets
Powder-Free	ASTM D 6124 - 01	Meets (2 mg/glove maximum)
Protein Level	ASTM D 5712 – 95

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).