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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 K890593
Device Name PATIENT EXAMINATION GLOVE
Applicant
Industri Getah Jacon
Lot 179-184, Alor Gejah
Ind.Est.Dist. Of
Alor Gajah Melaka,  MY 78000
Applicant Contact JACK B RUBIN
Correspondent
Industri Getah Jacon
Lot 179-184, Alor Gejah
Ind.Est.Dist. Of
Alor Gajah Melaka,  MY 78000
Correspondent Contact JACK B RUBIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/06/1989
Decision Date 04/05/1989
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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