MCare®Powder-free Nitrile Blue Examination Gloves With Chemotherapy Drugs Labeling Claimed

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 Blue Examination Gloves With Chemotherapy Drugs Labeling Claimed.

Pre-market Notification Details

• Device ID: K190876
• 510k Number: K190876
• Device Name: MCare®Powder-free Nitrile Blue Examination Gloves With Chemotherapy Drugs Labeling Claimed
• Classification: Polymer Patient Examination Glove
• Applicant: Mercator Medical (Thailand) LTD. 88/8, 88/9 Moo 12 Tambon Kampaengphet Amphur Rattaphum, TH 90180
• Contact: Dariusz Jan Krezymon
• Correspondent: Kevin Walls; Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-04-04
• Decision Date: 2019-12-02