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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K904130
Device Name CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL)
Applicant
BIOSAFETY SYSTEMS, INC.
8380 CAMINO SANTA FE
SAN DIEGO,  CA  92121
Applicant Contact COUTURE JR
Correspondent
BIOSAFETY SYSTEMS, INC.
8380 CAMINO SANTA FE
SAN DIEGO,  CA  92121
Correspondent Contact COUTURE JR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/05/1990
Decision Date 10/10/1990
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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