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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K081971
Device Name BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES
Applicant
Nitritex (M) Sdn. Bhd.
Kebun Baru, Jln Masjid
Telok Panglima Garang
Kuala Langat, Selangor De,  MY 42500
Applicant Contact DEREK WATTS
Correspondent
Nitritex (M) Sdn. Bhd.
Kebun Baru, Jln Masjid
Telok Panglima Garang
Kuala Langat, Selangor De,  MY 42500
Correspondent Contact DEREK WATTS
Regulation Number880.6250
Classification Product Code
LZC  
Date Received07/10/2008
Decision Date 12/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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