Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615978

FEI Number

3003045222

Entity Name

SHANGHAI MOTEX HEALTHCARE CO., LTD.

City/State/Country

SHANGHAI, CN

Establishment Address

NO. 369, JIASONG ZHONG ROAD, HUAXIN, QINGPU, SHANGHAI 201708, CN

Establishment Type(s)

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

Owner / Operator

SHANGHAI MOTEX HEALTHCARE CO., LTD. (Owner Number: 9041164)

Owner / Operator Contact Address

NO. 369, JIASONG ZHONG ROAD, HUAXIN, QINGPU, SHANGHAI, CN-SH 201708, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K013261

PMA Number

N/A

All Registered Proprietary Names

Shanghai Motex Modern Healthcare POWDER-FREE NITRILE EXAMINATION GLOVES Motex Powder-Free Nitrile Surgical Gloves Nitrile Powder-Free Examination Gloves, ProBlue #7235, #7735 Motex Powdered Nitrile Surgical Gloves; Item 6010 White, 6010 Green Modern Healthcare Shanghai 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	2007-11-18
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-05-11
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2014-12-28
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-05-11
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2014-06-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-18

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

SHANGHAI MOTEX HEALTHCARE 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
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

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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 9615978. Last updated year: 2026. Please use registration number 9615978 when referencing this establishment in official correspondence.