MCare® Powder Free Nitrile Black Examination Glove

Polymer Patient Examination Glove

Mercator Medical (Thailand) LTD.

The following data is part of a premarket notification filed by Mercator Medical (thailand) Ltd. with the FDA for Mcare® Powder Free Nitrile Black Examination Glove.

Pre-market Notification Details

• Device ID: K192444
• 510k Number: K192444
• Device Name: MCare® Powder Free Nitrile Black Examination Glove
• Classification: Polymer Patient Examination Glove
• Applicant: Mercator Medical (Thailand) LTD. 88/8 Moo 12 Tambon Kampaengphet Amphur Rattaphum, TH 90180
• Contact: Praneet Inthajak
• Correspondent: Praneet Inthajak; Mercator Medical (Thailand) LTD. 88/8 Moo 12 Tambon Kampaengphet Amphur Rattaphum, TH 90180
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-06
• Decision Date: 2019-12-31