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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 K890976
Device Name PATIENT EXAMINATION GLOVE
Applicant
Cranberry (M) Sdn. Bhd.
Lot 85, Jalan Portland,
Tasek Industrial Estate
Ipoh Perak,  MY 31400
Applicant Contact TEO, CHUAH
Correspondent
Cranberry (M) Sdn. Bhd.
Lot 85, Jalan Portland,
Tasek Industrial Estate
Ipoh Perak,  MY 31400
Correspondent Contact TEO, CHUAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/27/1989
Decision Date 04/18/1989
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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