The following data is part of a premarket notification filed by Mercator Medical (thailand) Ltd. with the FDA for Mcare Pf Powder Free Latex Examination High Risk Gloves.
| Device ID | K141042 |
| 510k Number | K141042 |
| Device Name: | MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | MERCATOR MEDICAL (THAILAND) LTD. 33 Golden Eagle Lane Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls MERCATOR MEDICAL (THAILAND) LTD. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-23 |
| Decision Date | 2015-03-19 |