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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 K896094
Device Name LATEX EXAMINATION GLOVES
Applicant
Matang Mfg. Sdn. Bhd.
83-A, Jalan Langkasuka, Larkin
Industrial Area, 80350 Johor
Bahru Johor Darul Takzim,  MY
Applicant Contact KRISHNAN SABAPATHY
Correspondent
Matang Mfg. Sdn. Bhd.
83-A, Jalan Langkasuka, Larkin
Industrial Area, 80350 Johor
Bahru Johor Darul Takzim,  MY
Correspondent Contact KRISHNAN SABAPATHY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/20/1989
Decision Date 01/17/1990
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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