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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K983334
Device Name NITRILE POWDER FREE EXAMINATION GLOVES
Applicant
Cranberry (M) Sdn. Bhd.
Lot 85, Jalan Portland,
Tasek Industrial Estate
Ipoh Perak,  MY 31400
Applicant Contact CHONG YOON TAT
Correspondent
Cranberry (M) Sdn. Bhd.
Lot 85, Jalan Portland,
Tasek Industrial Estate
Ipoh Perak,  MY 31400
Correspondent Contact CHONG YOON TAT
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/23/1998
Decision Date 02/19/1999
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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