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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 K093696
Device Name SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803
Applicant
Central Medicare Sdn Bhd
1930 Brea Canyon Rd.,
#240,Diamond Bar
Diamond Bar,  CA  91765
Applicant Contact NICK WANG
Correspondent
Central Medicare Sdn Bhd
1930 Brea Canyon Rd.,
#240,Diamond Bar
Diamond Bar,  CA  91765
Correspondent Contact NICK WANG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/30/2009
Decision Date 02/12/2010
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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