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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 K061659
Device Name POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
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
LYZ  
Date Received06/12/2006
Decision Date 09/15/2006
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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