Cleared Traditional

COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE

K001042 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital

May 2000

Decision

53d

Days

Class 1

Risk

About This 510(k) Submission

K001042 is an FDA 510(k) clearance for the COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE, 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 May 23, 2000, 53 days after receiving the submission on March 31, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K001042 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2000
Decision Date	May 23, 2000
Days to Decision	53 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.