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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 K895743
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Rubbertech Industry Co., Ltd.
Suite 801, Floor Magnum Plz.,
128 Jalan Pudu, 55100 Kuala
Lumpur, Malaysia,  MY
Applicant Contact JAMROEN JAROENVITHES
Correspondent
Rubbertech Industry Co., Ltd.
Suite 801, Floor Magnum Plz.,
128 Jalan Pudu, 55100 Kuala
Lumpur, Malaysia,  MY
Correspondent Contact JAMROEN JAROENVITHES
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/26/1989
Decision Date 10/13/1989
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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