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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 K000667
Device Name POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM
Applicant
Protection Gloves Sdn. Bhd.
Lot # 236, Batu 2 1/2,
Jalan Yong Peng
Chaah, Johor,  MY 85400
Applicant Contact THIRUNAVUKARASU PEARIASAMY
Correspondent
Protection Gloves Sdn. Bhd.
Lot # 236, Batu 2 1/2,
Jalan Yong Peng
Chaah, Johor,  MY 85400
Correspondent Contact THIRUNAVUKARASU PEARIASAMY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/28/2000
Decision Date 04/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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