The following data is part of a premarket notification filed by Mercator Medical (thailand) Ltd. with the FDA for Mcare(r) Powder Free Nitrile Orange Examination Gloves.
| Device ID | K200967 |
| 510k Number | K200967 |
| Device Name: | MCare(R) Powder Free Nitrile Orange Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Mercator Medical (Thailand) LTD. 88/8 Moo 12 Tambon Kampaengphet Amphur Rattaphum, TH 90180 |
| Contact | Dariusz Jan Krezymon |
| 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 | 2020-04-10 |
| Decision Date | 2020-06-06 |