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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 K993760
Device Name POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS
Applicant
Hartalega Sdn Bhd
9 Jalan Kuang Bulan Taman
Kepong Industrial Estate
Kuala Lumpur,  MY 52100
Applicant Contact KUAN KAM HON
Correspondent
Hartalega Sdn Bhd
9 Jalan Kuang Bulan Taman
Kepong Industrial Estate
Kuala Lumpur,  MY 52100
Correspondent Contact KUAN KAM HON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/08/1999
Decision Date 05/15/2000
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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