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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 K892021
Device Name SUNNY TEX (PATIENT EXAMINATION GLOVES)
Applicant
P.T. Indotama Megah Indah Rubber
605 S. Arroyo Pkwy.
Pasadena,  CA  91105
Applicant Contact CATHERINA C CHU
Correspondent
P.T. Indotama Megah Indah Rubber
605 S. Arroyo Pkwy.
Pasadena,  CA  91105
Correspondent Contact CATHERINA C CHU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/30/1989
Decision Date 09/15/1989
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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