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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 K891244
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Ganda Yakin Sdn Bhd
Suite 18b, 18th Floor Office Tow
Kompleks Nagaria, 12 Jalan
Imbi, 55100 Kuala Lumpur,  MY
Applicant Contact HONG CHEW
Correspondent
Ganda Yakin Sdn Bhd
Suite 18b, 18th Floor Office Tow
Kompleks Nagaria, 12 Jalan
Imbi, 55100 Kuala Lumpur,  MY
Correspondent Contact HONG CHEW
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/08/1989
Decision Date 06/02/1989
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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