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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 K892174
Device Name LATEX EXAMINATION GLOVES (WINTEX)
Applicant
Windwell Agencies Sdn. Bhd.
# 3, Lorong Helang Hindik
Kepong Baru Ind.Estate Kepong
Baru, Kual Lumpur,  MY 52100
Applicant Contact MINORU YAMASAKI
Correspondent
Windwell Agencies Sdn. Bhd.
# 3, Lorong Helang Hindik
Kepong Baru Ind.Estate Kepong
Baru, Kual Lumpur,  MY 52100
Correspondent Contact MINORU YAMASAKI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/05/1989
Decision Date 08/23/1989
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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