Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010582952

FEI Number

3010582952

Entity Name

HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

Xingtai Hebei, CN

Establishment Address

Eastern Industrial Zone, Nangong, Xingtai Hebei 051800, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY CO.,LTD (Owner Number: 10045284)

Owner / Operator Contact Address

Eastern industrial accumulation area,, Nangong, Xingtai, CN-HE 051800, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150340

PMA Number

N/A

All Registered Proprietary Names

Powder Free Blue Nitrile Examination Gloves, Tested for Use With Chemotherapy Drugs Powder Free Blue Nitrile Gloves, Tested For Use With Chemotherapy Drugs Single-Use Medical Poly (Vinyl Chloride) Examination Glove (Clear, Non-Colored) Power Free Green Nitrile Examination Gloves (XS/S/M/L/XL) Power Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Power Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) Powder Free Nitrile Patient Examination Gloves, Blue Examination Gloves Powder Free Nitrile Gloves(White) Powder Free Nitrile Gloves(Ice Blue) Powder Free Nitrile Gloves(Black) Powder Free Nitrile Gloves(Cobalt Blue)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2018-09-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-09-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-02-21
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-02-21
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2021-02-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-07-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-11-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-08-24
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2015-06-18

Official Correspondent

JIAO LU

US Agent Details

Wen Xu Email: infor@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

HEBEI TITANS HONGSEN MEDICAL TECHNOLOGY 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
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
3013681444	ANREL DISTRIBUTION LLC	Jackson, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010582952. Last updated year: 2026. Please use registration number 3010582952 when referencing this establishment in official correspondence.