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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 K893696
Device Name PATIENT EXAM GLOVES(MFG: JIN DING ZAI JIE LATEX GL
Applicant
Double Scores , Ltd.
Suite 3502, 35/F., Bond Centre
East Tower, 89 Queensway
Hong Kong,  HK
Applicant Contact K. M WONG
Correspondent
Double Scores , Ltd.
Suite 3502, 35/F., Bond Centre
East Tower, 89 Queensway
Hong Kong,  HK
Correspondent Contact K. M WONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/16/1989
Decision Date 09/29/1989
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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