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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 K893325
Device Name LATEX EXAMINATION GLOVES
Applicant
Hin Fatt Corp. Sdn Bhd
16a (First Floor ), Lorong
Meranti Satu, Off Jalan Kenan-
Ga, 55200 Kuala Lumpur,  MY
Applicant Contact CHEONG
Correspondent
Hin Fatt Corp. Sdn Bhd
16a (First Floor ), Lorong
Meranti Satu, Off Jalan Kenan-
Ga, 55200 Kuala Lumpur,  MY
Correspondent Contact CHEONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/19/1989
Decision Date 08/17/1989
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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