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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 K892619
Device Name LATECHNICS LATEX EXAMINATION GLOVES
Applicant
Ssangyong Corp. (M) Sdn. Bhd.
Lot: 112, Jalan Dua D
Subang New Village, 40000 Shah
Alam,Selangor Darul Ehsan,  MY
Applicant Contact EE BEE
Correspondent
Ssangyong Corp. (M) Sdn. Bhd.
Lot: 112, Jalan Dua D
Subang New Village, 40000 Shah
Alam,Selangor Darul Ehsan,  MY
Correspondent Contact EE BEE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/10/1989
Decision Date 01/26/1990
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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