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 |