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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 K892679
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Mastervest Corp. Sdn Bhd.
279a Jalan Mahkota, Taman
Maluri, Cheras, 55100 Kuala
Lumpur, Malaysia,  MY
Applicant Contact HOOI KEONG
Correspondent
Mastervest Corp. Sdn Bhd.
279a Jalan Mahkota, Taman
Maluri, Cheras, 55100 Kuala
Lumpur, Malaysia,  MY
Correspondent Contact HOOI KEONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/1989
Decision Date 05/12/1989
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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