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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 K001834
Device Name SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
Applicant
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD.
12390 EAST END AVE.
CHINO,  CA  91710
Applicant Contact JAMES CHU
Correspondent
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD.
12390 EAST END AVE.
CHINO,  CA  91710
Correspondent Contact JAMES CHU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/16/2000
Decision Date 06/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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