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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 K904443
Device Name PATIENT EXAMINATION GLOVES
Applicant
Pisak Enterprise Co., Ltd.
C/O Cypress Medical Product
1110 Lake Cook Rd., Suite 275
Buffalo Grove,  IL  60089
Applicant Contact VARUN SONI
Correspondent
Pisak Enterprise Co., Ltd.
C/O Cypress Medical Product
1110 Lake Cook Rd., Suite 275
Buffalo Grove,  IL  60089
Correspondent Contact VARUN SONI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/28/1990
Decision Date 10/17/1990
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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