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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 K102152
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
Hebei Tengda Plastic Co., Ltd.
Rm. 1606 Bldg.1 Jianxiang Yua
#209 Bei Si Huan Zhong Rd.
Shijiazhuang,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
Hebei Tengda Plastic Co., Ltd.
Rm. 1606 Bldg.1 Jianxiang Yua
#209 Bei Si Huan Zhong Rd.
Shijiazhuang,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/30/2010
Decision Date 04/28/2011
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
Recalls CDRH Recalls
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