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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 K022701
Device Name POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E
Applicant
Perusahaan Getah Asas Sdn. Bhd.
Lot 754, Jalan Haji Sirat
Selangor,  MY 41720
Applicant Contact TAN KONG CHANG
Correspondent
Perusahaan Getah Asas Sdn. Bhd.
Lot 754, Jalan Haji Sirat
Selangor,  MY 41720
Correspondent Contact TAN KONG CHANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/14/2002
Decision Date 09/17/2002
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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