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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 K093276
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
TANGSHAN KANGYUAN GLOVE CO., LTD.
RM 1606 BLDG. 1. JIANXING YUAN
NO. 209 BEI SI HUAN
BEIJING,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
TANGSHAN KANGYUAN GLOVE CO., LTD.
RM 1606 BLDG. 1. JIANXING YUAN
NO. 209 BEI SI HUAN
BEIJING,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/19/2009
Decision Date 11/04/2009
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
Recalls CDRH Recalls
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