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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 K893449
Device Name LATEX EXAMINATION GLOVES
Applicant
Lon Tai Chemical Industrial Co., Ltd.
Lot 3, Lorong P/1b, Sec. B
Bandar Baru Bangi, 43000
Selangor Darul Ehsan,  MY
Applicant Contact H CHEONG
Correspondent
Lon Tai Chemical Industrial Co., Ltd.
Lot 3, Lorong P/1b, Sec. B
Bandar Baru Bangi, 43000
Selangor Darul Ehsan,  MY
Correspondent Contact H CHEONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/03/1989
Decision Date 09/18/1989
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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