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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 K891272
Device Name 'QUEST', 'PELANGI' PATIENT EXAM GLOVES (LATEX)
Applicant
Pelangi Rubber Products Sdn. Bhd.
Mlo Lot 2568, Batu 6, Jalan
Skudai, 81200 Johor Bahru
Negeri Johor Darul Takzim,  MY
Applicant Contact JIT SOUN
Correspondent
Pelangi Rubber Products Sdn. Bhd.
Mlo Lot 2568, Batu 6, Jalan
Skudai, 81200 Johor Bahru
Negeri Johor Darul Takzim,  MY
Correspondent Contact JIT SOUN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/09/1989
Decision Date 04/26/1989
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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