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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K070404
Device Name NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
Applicant
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD.
NO. 209 BEI SI HUAN ZHONG ROAD
HAIDIAN DISTRICT
BEIJING,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
TANGSHAN LUXIONG PLASTIC PRODUCTS CO., LTD.
NO. 209 BEI SI HUAN ZHONG ROAD
HAIDIAN DISTRICT
BEIJING,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/12/2007
Decision Date 03/26/2007
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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