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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 K000071
Device Name SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
Applicant
SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD
12390 EAST END AVE.
CHINO,  CA  91710
Applicant Contact JAMES CHU
Correspondent
SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD
12390 EAST END AVE.
CHINO,  CA  91710
Correspondent Contact JAMES CHU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received01/10/2000
Decision Date 02/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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