# Mercator Medical (Thailand), Ltd.

- Location (FDA's records): Amphur Rattaphum, TH
- FDA decisions: 7 (2015–2025): 7 510(k) clearances
- Product codes: LZA (6), LYY (1)
- 510(k) review time since 2016: median 158 days, against 145 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Latexx Manufacturing Sdn.Bhd.: 1 (https://510kreport.com/company/latexx-manufacturing-sdn-bhd)

## Firms that cite its devices most
- Jr Engineering & Medical Technologies (M) Sdn. Bhd.: 2 (https://510kreport.com/company/jr-engineering-medical-technologies-m-sdn-bhd)
- Lienteh Technology Sdn Bhd: 1 (https://510kreport.com/company/lienteh-technology-sdn-bhd)
- Novid Ppe Sdn. Bhd.: 1 (https://510kreport.com/company/novid-ppe-sdn-bhd)

## Its most-cited devices
- K172930: mCare Powder-free Blue Nitrile Examination Gloves (2018), cited by 3
- K141042: Mcare PF Powder Free Latex Examination High Risk Gloves (2015), cited by 1

## Recent decisions
- K251141: 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 (Nov 17, 2025)
- K213548: Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy (Feb 21, 2022)
- K200967: mCare (R) Powder Free Nitrile Orange Examination Gloves (Jun 6, 2020)
- K192444: mCare® Powder Free Nitrile Black Examination Glove (Dec 31, 2019)
- K190876: mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed (Dec 2, 2019)
- K172930: mCare Powder-free Blue Nitrile Examination Gloves (Apr 13, 2018)
- K141042: Mcare PF Powder Free Latex Examination High Risk Gloves (Mar 19, 2015)

Source page: https://510kreport.com/company/mercator-medical-thailand