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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 K143277
Device Name Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile),
Applicant
Lifestyle Safety Products (Hui Zhou) Co., Ltd.
Daxiaotang Village, Luoyang Town
Boluo County
Huizhou City,  CN 516120
Applicant Contact Lee Hong Chong
Correspondent
Registar Corp
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact Rhonda Alexander
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received11/14/2014
Decision Date 07/29/2015
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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