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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 K110314
Device Name STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)
Applicant
True Glove Factory
#6-1 Xingan Rd. E., Linqu
Weifang, Shandong,  CN 262600
Applicant Contact FRANK YANG
Correspondent
True Glove Factory
#6-1 Xingan Rd. E., Linqu
Weifang, Shandong,  CN 262600
Correspondent Contact FRANK YANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/02/2011
Decision Date 05/10/2011
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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