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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 K112693
Device Name NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES
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
LYY  
Date Received09/15/2011
Decision Date 09/12/2012
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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