510(k) Premarket Notification

• Device Classification Name: latex patient examination glove
• 510(K) Number: K100694
• Device Name: COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN
• Applicant: TEKMEDIC (M) SDN BHD; plot 4, tanjung kling; industrial area, tanjung bruas; jetty, tanjung kling, melaka,
• Contact: patrick leong
• Regulation Number: 880.6250
• Classification Product Code: LYY
• Date Received: 03/11/2010
• Decision Date: 06/25/2010
• 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