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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 K946111
Device Name PROSHIELD PLUS MULTIPLE
Applicant
Sino (U.S.A.) Co.
19618 E. Vega
Rowland Heights,  CA  91748
Applicant Contact KAREN ABELL
Correspondent
Sino (U.S.A.) Co.
19618 E. Vega
Rowland Heights,  CA  91748
Correspondent Contact KAREN ABELL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/15/1994
Decision Date 04/25/1995
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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