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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 K891885
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Alfaseal Sdn. Bhd.
Suite 162, 16th Floor
Wisma Mirama-Jalan Wisma Putra
50460 Kuala Lumpur,  MY
Applicant Contact ROBIN CHEW
Correspondent
Alfaseal Sdn. Bhd.
Suite 162, 16th Floor
Wisma Mirama-Jalan Wisma Putra
50460 Kuala Lumpur,  MY
Correspondent Contact ROBIN CHEW
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/28/1989
Decision Date 04/11/1989
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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