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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 K980916
Device Name POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Applicant
Perusahaan Getah Asas Sdn. Bhd.
Lot 754, Jalan Haji Sirat
Off Jalan Kapar, Klang
Selangor, Darul Ehsan,  MY 42100
Applicant Contact BOB CHAN
Correspondent
Perusahaan Getah Asas Sdn. Bhd.
Lot 754, Jalan Haji Sirat
Off Jalan Kapar, Klang
Selangor, Darul Ehsan,  MY 42100
Correspondent Contact BOB CHAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/11/1998
Decision Date 08/18/1998
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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