Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013565389

FEI Number

3013565389

Entity Name

SHANXI HONGJIN PLASTIC TECHNOLOGY CO., LTD

City/State/Country

Linfen Shanxi, CN

Establishment Address

Coal Bed Gas Industrial Zone, Qu'e Town, Daning county, Linfen Shanxi 042300, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shanxi Hongjin Plastic Technology Co., LTD (Owner Number: 10054957)

Owner / Operator Contact Address

Coal Bed Gas Industrial Zone, Qu'e Town, Daning county, Linfen, CN-SX 042300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2022-08-07
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-08-07
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2022-08-07
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-08-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-07-05
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2022-05-18
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-11-06
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-11-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-11-06
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-11-06
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-01-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-01-03
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2024-01-03
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-01-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-07-08
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-07-13
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-11-04
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-11-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-11-27
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2017-05-17
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2022-06-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-11-19

Official Correspondent

Zhigang Wu

US Agent Details

Kathy Liu Email: registration@csrepresent.com Phone: (909) 5901611

Related Public Records

Same Entity

Shanxi Hongjin Plastic 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
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 3013565389. Last updated year: 2026. Please use registration number 3013565389 when referencing this establishment in official correspondence.