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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 K082597
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Applicant
TANGSHAN LINYUAN PLASTIC PRODUCTS CO., LTD
ROOM 1606 BLDG. 1 JIANXIANG
YUAN NO.209 BEI SI HUAN ZHC
BEIJING,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
TANGSHAN LINYUAN PLASTIC PRODUCTS CO., LTD
ROOM 1606 BLDG. 1 JIANXIANG
YUAN NO.209 BEI SI HUAN ZHC
BEIJING,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/08/2008
Decision Date 10/24/2008
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
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