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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 K892972
Device Name 'JOBSTAR' PATIENT EXAMINATION GLOVES
Applicant
Kai Sik Towa Rubber Products Sdn
2459, Lorong Perusahaan 10
Perai Indust. Estate, 13600
Perai, Penang, Malaysia,  MY
Applicant Contact CHOO ENG
Correspondent
Kai Sik Towa Rubber Products Sdn
2459, Lorong Perusahaan 10
Perai Indust. Estate, 13600
Perai, Penang, Malaysia,  MY
Correspondent Contact CHOO ENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/12/1989
Decision Date 09/26/1989
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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