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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 K891749
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Ocean Pacific Med Tec
2303 Douglas Rd.
Burnaby, B.C. V5c 5a9
Burnaby B C V5c 5a9,  CA
Applicant Contact CRAIG HOGARTH
Correspondent
Ocean Pacific Med Tec
2303 Douglas Rd.
Burnaby, B.C. V5c 5a9
Burnaby B C V5c 5a9,  CA
Correspondent Contact CRAIG HOGARTH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/22/1989
Decision Date 07/14/1989
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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