510(k) Premarket Notification

• Device Classification Name: polymer patient examination glove
• 510(K) Number: K122999
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
• Applicant: TOP GLOVE SDN. BHD.; lot 4968, batu 6,jalan teratai; off jalan meru; klang, selangor,
• Contact: eddy rosaydie
• Regulation Number: 880.6250
• Classification Product Code: LZA
• Subsequent Product Code: LZC
• Date Received: 09/27/2012
• Decision Date: 11/30/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: General Hospital
• Review Advisory Committee: General Hospital
• statement: statement
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No