Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010201834

FEI Number

3010201834

Entity Name

ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD.

City/State/Country

Tangshan Hebei, CN

Establishment Address

West Industrial Park, BDA, Luannan County, Tangshan Hebei 063500, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhonghong Pulin Medical Products Co.,Ltd. (Owner Number: 10051679)

Owner / Operator Contact Address

Pachigang Industrial Park,Luannan County, Tangshan, CN-HE 063502, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230662

PMA Number

N/A

All Registered Proprietary Names

nitrile gloves Polymer patient examination glove NITRILE EXAM GLOVES Polymer patient examination gloveMedical Glove, Specialty Polymer patient examination glove Polymer patient examination gloveMedical Glove, SpecialtyMedical gloves with chemotherapy labeling claims - test for use Polymer patient examination gloveMedical Glove, SpecialtyMedical gloves with chemotherapy labeling claims - test for use

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	2026-01-13
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2026-01-24
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-02-12
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2018-02-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-04-19
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2024-12-19
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-12-19
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-12-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-12-19
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2024-12-19
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-12-19
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-12-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-12-19

Official Correspondent

Chao Kevin

US Agent Details

Da Shi Email: info@medicaldevice.org Phone: (949) 7678188

Related Public Records

Same Entity

Zhonghong Pulin Medical Products 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

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3043739177	US Paper Mill LLC	Chillicothe, OH, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010201834. Last updated year: 2026. Please use registration number 3010201834 when referencing this establishment in official correspondence.