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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 K964321
Device Name GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)
Applicant
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
NO. 135 XIN-HUA WEST RD.
SHIJIAZHUANG,  CN
Applicant Contact LIN CHIN YU
Correspondent
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
NO. 135 XIN-HUA WEST RD.
SHIJIAZHUANG,  CN
Correspondent Contact LIN CHIN YU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/29/1996
Decision Date 01/09/1997
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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