Cleared Traditional

PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR

K002065 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital

Aug 2000

Decision

46d

Days

Class 1

Risk

About This 510(k) Submission

K002065 is an FDA 510(k) clearance for the PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Comfort Rubber Gloves Industries Sdn. Bhd. (Matang, MY). The FDA issued a Cleared decision on August 22, 2000, 46 days after receiving the submission on July 7, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K002065 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2000
Decision Date	August 22, 2000
Days to Decision	46 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	LYY — Latex Patient Examination Glove
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.