Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004577220

FEI Number

3004577220

Entity Name

MERCATOR MEDICAL (THAILAND) LTD.

City/State/Country

Ratthaphum Songkhla, TH

Establishment Address

88/8, 88/9, 88/10 Moo 12,, Tambon Kampaengphet,, Ratthaphum Songkhla 90180, TH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Mercator Medical (Thailand) Ltd. (Owner Number: 9063727)

Owner / Operator Contact Address

88/8, 88/9, 88/10 Moo 12, Tambon Kampaengphet, Amphur Rattaphum, TH-90 90180, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251141

PMA Number

N/A

All Registered Proprietary Names

PF Nitrile Orange Examination Gloves Nitrylex® classic, Nitrylex® classic plus, Nitrylex® long Confiderm Powder Free Nitrile Black Examination Glove Non-sterile Powder Free Nitrile Black Examination Gloves - MidKnight XTRA 93-862 Blue and Black Nitrile Gloves with Chemotherapy drugs labeling

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-06-07
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-02-22
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-02-22
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-01-05
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2025-12-10
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-12-10
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-12-10
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-12-10

Official Correspondent

Pamila Suzuki

US Agent Details

KEVIN WALLS Business: Principal Consultant, Regulartory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

Mercator Medical (Thailand) Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21
K101595	Better Care Plastic Technology Cp., Ltd.	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE	2010-08-06

Similar Registrations

Registration Number	Establishment Name	Location
3030671502	GUANGDONG VYIMED CO., LTD.	Qingyuan Guangdong, CN
9610406	ANSELL (THAILAND) LTD.	THAILAND Krung Thep Maha Nakhon, TH
3026062711	RMKH GLOVE (CAMBODIA) CO., LTD.	Bavet City Svay Rieng, KH
3043739177	US Paper Mill LLC	Chillicothe, OH, US
3042765418	VITAL EDGE INSTRUMENTS LLC	Leesburg, VA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004577220. Last updated year: 2026. Please use registration number 3004577220 when referencing this establishment in official correspondence.