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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 K903111
Device Name LATEX EXAMINATION GLOVES
Applicant
Kaen Yang Industry Co., Ltd.
C/O W.P. Gratitude Co. Ltd.
1448/8 Pahonyotin Rd., Bangkhen
Bangkok 10900 Thailand,  TH
Applicant Contact WORAWIT PITAKANOND
Correspondent
Kaen Yang Industry Co., Ltd.
C/O W.P. Gratitude Co. Ltd.
1448/8 Pahonyotin Rd., Bangkhen
Bangkok 10900 Thailand,  TH
Correspondent Contact WORAWIT PITAKANOND
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/11/1990
Decision Date 10/26/1990
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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