Medical Device Manufacturer · US , Littleton , CO

Mercator Medical (Thailand), Ltd.

7 submissions · 7 cleared · Since 2015
7
Total
7
Cleared
0
Denied

Mercator Medical (Thailand), Ltd. — FDA 510(k) Submissions

Mercator Medical (Thailand), Ltd. has submitted 7 FDA 510(k) premarket notifications since 2015, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Polymer Patient Examination Glove, Latex Patient Examination Glove . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K251141 · LZA Polymer Patient... · General Hospital
Nov 2025 217d
Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
K213548 · LZA Polymer Patient... · General Hospital
Feb 2022 105d
mCare(R) Powder Free Nitrile Orange Examination Gloves
K200967 · LZA Polymer Patient... · General Hospital
Jun 2020 57d
mCare? Powder Free Nitrile Black Examination Glove
K192444 · LZA Polymer Patient... · General Hospital
Dec 2019 116d
mCare?Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
K190876 · LZA Polymer Patient... · General Hospital
Dec 2019 242d
mCare Powder-free Blue Nitrile Examination Gloves
K172930 · LZA Polymer Patient... · General Hospital
Apr 2018 200d
MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
K141042 · LYY Latex Patient Examination... · General Hospital
Mar 2015 330d
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