HIGH FIVE

Polymer Patient Examination Glove

CENTRAL MEDICARE SDN BHD

The following data is part of a premarket notification filed by Central Medicare Sdn Bhd with the FDA for High Five.

Pre-market Notification Details

• Device ID: K113440
• 510k Number: K113440
• Device Name: HIGH FIVE
• Classification: Polymer Patient Examination Glove
• Applicant: CENTRAL MEDICARE SDN BHD 1930 BREA CANYON ROAD DIAMOND BAR Diamond Bar, CA 91765
• Contact: Nick Wang
• Correspondent: Nick Wang; CENTRAL MEDICARE SDN BHD 1930 BREA CANYON ROAD DIAMOND BAR Diamond Bar, CA 91765
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-11-21
• Decision Date: 2012-05-23
• Summary: summary