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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 K042805
Device Name POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
Applicant
Perusahaan Getah Asas Sdn. Bhd.
Lot 754, Jalan Haji Sirat
Klang, Selangor,  MY 42100
Applicant Contact KK LEONG
Correspondent
Perusahaan Getah Asas Sdn. Bhd.
Lot 754, Jalan Haji Sirat
Klang, Selangor,  MY 42100
Correspondent Contact KK LEONG
Regulation Number880.6250
Classification Product Code
LZC  
Date Received10/12/2004
Decision Date 12/16/2004
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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