What does Zhonghong Pulin Medical Products Co., Ltd. manufacture?

Registered with the FDA for 4 device types.

Is Zhonghong Pulin Medical Products Co., Ltd. still registered with the FDA?

Yes. The registration is current and expires 2026.

Zhonghong Pulin Medical Products Co., Ltd. → Supplier → Allomedo

Zhonghong Pulin Medical Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Medical Glove, Specialty, Polymer Patient Examination Glove and 2 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.

4device types registered with the FDA

2products catalogued under its own name

5510(k) clearances

Registration

FDA registration record for Zhonghong Pulin Medical Products Co., Ltd.
Registered name	ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD.
Status	Registered
Registration expires	2026
Registration number	3010201834
FEI number	3010201834
DUNS	548208657
Establishment type	Contract manufacturer, Specification developer, Manufacturer

Chinese Registration

Chinese company register details for Zhonghong Pulin Medical Products Co., Ltd.
Chinese legal name	中红普林医疗用品股份有限公司
Source	Baidu Baike

Location

Address of Zhonghong Pulin Medical Products Co., Ltd.
City	Tangshan
Province	Hebei
Address	West Industrial Park, BDA, Luannan County
Postal code	063500
Country	China

What It Makes

Device types Zhonghong Pulin Medical Products Co., Ltd. is registered to make
Device type	Class	Listed under the names	Listed since	Chinese makers
Fentanyl And Other Opioid Protection Glove	Class 1	Polymer patient examination gloveMedical Glove, SpecialtyMedical gloves with chemotherapy labeling claims – test for use	2024	29
Medical Glove, Specialty	Class 1	Polymer patient examination gloveMedical Glove, SpecialtyMedical gloves with chemotherapy labeling claims – test for use, Polymer patient examination gloveMedical Glove, Specialty	2018	48
Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs	Class 1	Polymer patient examination gloveMedical Glove, SpecialtyMedical gloves with chemotherapy labeling claims – test for use	2024	32
Polymer Patient Examination Glove	Class 1	nitrile gloves, Polymer patient examination glove, Polymer patient examination gloveMedical Glove, SpecialtyMedical gloves with chemotherapy labeling claims – test for use, Polymer patient examination gloveMedical Glove, Specialty, Nitrile Exam Gloves	2016	83

Own-Brand Listings

Devices catalogued by Zhonghong Pulin Medical Products Co., Ltd.
Product	Code	Catalogue numbers
Zhonghong Pulin	LYZ	1
Zhonghong Pulin	LZA	1

Clearances

5 clearances name Zhonghong Pulin Medical Products Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Zhonghong Pulin Medical Products Co., Ltd. or its listings
Clearance	Decision date	Product code	Route	Held by
K231029	2023-10-30	LZA	Traditional	This company
K230662	2023-10-26	LZA	Traditional	This company
K210460	2021-05-17	LYZ	Traditional	This company
K171873	2017-11-15	LZA	Traditional	This company
K152712	2016-03-09	LZA	Traditional	This company
K152720	2016-03-10	LZA	Traditional	Xingda Medical Products Co., Ltd.
K082598	2009-01-07	LZA	Traditional	Tangshan Zhonghong Pulin Group Co., Ltd.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Zhonghong Pulin Medical Products Co., Ltd.
Founded	2010
Main products	Disposable exam and surgical gloves, Disposable infusion sets, Protective equipment, Portable analgesic pumps, Enteral feeding pumps
Export markets	80+ countries (North America, Europe, Japan)

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer	Device types
Tangshan Zhengtong Exhibition Co., Ltd.	34
Zhongnuo Medical Products Co., Ltd.	3

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Zhonghong Pulin Medical Products Co., Ltd.