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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 K890931
Device Name PATIENT EXAMINATION GLOVE
Applicant
Phutex Products Co., Ltd.
19 Railside Rd., Don Mills
Ontario
Canada,  ID
Applicant Contact WAYNE DRISCOLL
Correspondent
Phutex Products Co., Ltd.
19 Railside Rd., Don Mills
Ontario
Canada,  ID
Correspondent Contact WAYNE DRISCOLL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/24/1989
Decision Date 06/23/1989
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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