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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 K890975
Device Name PATIENT EXAMINATION GLOVE
Applicant
Kleartex Sdn Bhd
Lot 2 Persiaran Sultan Sec 15
Shah Alam Ind Est Shah Alam
Selangor Darul Ehsan,  MY 40000
Applicant Contact CHE LAH
Correspondent
Kleartex Sdn Bhd
Lot 2 Persiaran Sultan Sec 15
Shah Alam Ind Est Shah Alam
Selangor Darul Ehsan,  MY 40000
Correspondent Contact CHE LAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/27/1989
Decision Date 05/11/1989
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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