Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042894943

FEI Number

3042894943

Entity Name

Toppro International Co., Ltd.

City/State/Country

Bangkok Krung Thep Maha Nakhon, TH

Establishment Address

1469/6 Soi Pattanakarn 31/1, Pattanakarn Road, Suanluang, Bangkok Krung Thep Maha Nakhon 10250, TH

Establishment Type(s)

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

Owner / Operator

Toppro International Co., Ltd. (Owner Number: 10094969)

Owner / Operator Contact Address

1469/6 Soi Pattanakarn 31/1,Pattanakarn Road, Suanluang, Bangkok, TH-NOTA 10250, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191898

PMA Number

N/A

All Registered Proprietary Names

MOTEX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2026-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

Toppro International Co., 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
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02

Similar Registrations

Registration Number	Establishment Name	Location
9610406	ANSELL (THAILAND) LTD.	THAILAND Krung Thep Maha Nakhon, TH
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3025413681	GUILIN HUADA BIOTECHNOLOGY CO., LTD.	Guilin City Guangxi, CN
8041005	WRP ASIA PACIFIC SDN. BHD.	SALAK TINGGI, SEPANG Selangor, MY
3004122598	PRODUCTOS MEDLINE S.A. DE C.V.	NUEVO LAREDO Tamaulipas, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042894943. Last updated year: 2026. Please use registration number 3042894943 when referencing this establishment in official correspondence.