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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 K121549
Device Name NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
Applicant
SIAM SEMPERMED CORP. LTD.
13900 49TH STREET NORTH
CLEARWATER,  FL  33762
Applicant Contact WILLIAM E HARRIS
Correspondent
SIAM SEMPERMED CORP. LTD.
13900 49TH STREET NORTH
CLEARWATER,  FL  33762
Correspondent Contact WILLIAM E HARRIS
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/25/2012
Decision Date 12/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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