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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K112741
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVE
Applicant
Lifestyle Safty Products (Hui Zhou) Co., Ltd.
Medical Device & Drug Devision
144 Research Dr.
Hampton,  VA  23666
Applicant Contact RHONDA T ALEXANDER
Correspondent
Lifestyle Safty Products (Hui Zhou) Co., Ltd.
Medical Device & Drug Devision
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact RHONDA T ALEXANDER
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/21/2011
Decision Date 09/13/2012
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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