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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K013443
Device Name POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2
Applicant
Maxter Glove Manufacturing Sdn Bhd
Lot 607, Jalan Haji Abdul
Manan
41050 Klang, Selangor,  MY 41050
Applicant Contact STANLEY THAI
Correspondent
Maxter Glove Manufacturing Sdn Bhd
Lot 607, Jalan Haji Abdul
Manan
41050 Klang, Selangor,  MY 41050
Correspondent Contact STANLEY THAI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/17/2001
Decision Date 11/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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