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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 K101646
Device Name NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
Applicant
Sgmp Co., Ltd.
198 Ave. De La D'Emerald
Sparks,  NV  89434
Applicant Contact JANNA P TUCKER
Correspondent
Sgmp Co., Ltd.
198 Ave. De La D'Emerald
Sparks,  NV  89434
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/11/2010
Decision Date 09/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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