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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 K954365
Device Name POWDER FREE LATEX EXAMINATION GLOVES
Applicant
Perusahaan Getah Asas Sdn. Bhd.
Lot 754, Jalan Haji Sirat
Off Jalan Kapar, P.O. Box 188
Selangor Darul Ehsan,  MY 41720
Applicant Contact LIM KUANG SIA
Correspondent
Perusahaan Getah Asas Sdn. Bhd.
Lot 754, Jalan Haji Sirat
Off Jalan Kapar, P.O. Box 188
Selangor Darul Ehsan,  MY 41720
Correspondent Contact LIM KUANG SIA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/18/1995
Decision Date 12/11/1995
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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