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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 K092966
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Applicant
JIN ZHOU CHANG HAO PLASTIC PRODUCTS CO., LTD.
RM1606 BLDG.1, JIAN XIANG YUAN
NO.209 BEI SI HUAN ZHONG RD.
BEIJING,  CN 100083.
Applicant Contact CHU XIAOAN
Correspondent
JIN ZHOU CHANG HAO PLASTIC PRODUCTS CO., LTD.
RM1606 BLDG.1, JIAN XIANG YUAN
NO.209 BEI SI HUAN ZHONG RD.
BEIJING,  CN 100083.
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/25/2009
Decision Date 12/08/2009
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
Predetermined Change
Control Plan Authorized		 No
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