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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 K102819
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
Hebei Hongtai Plastic Products Co., Ltd.
Rm. 3-402, No 71
Majiapu Yangqiao, Fengtai Dist
Beijing,  CN 100068
Applicant Contact RICHARD LU
Correspondent
Hebei Hongtai Plastic Products Co., Ltd.
Rm. 3-402, No 71
Majiapu Yangqiao, Fengtai Dist
Beijing,  CN 100068
Correspondent Contact RICHARD LU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/28/2010
Decision Date 12/23/2010
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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