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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 K943735
Device Name PROSHIELD PLUS MULTIPLE GLOVES
Applicant
Sino (U.S.A.) Co.
19618 E. Vega
Rowland Heights,  CA  91748
Applicant Contact FRANK LIU
Correspondent
Sino (U.S.A.) Co.
19618 E. Vega
Rowland Heights,  CA  91748
Correspondent Contact FRANK LIU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/02/1994
Decision Date 09/16/1994
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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