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 |