Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012304513

FEI Number

3012304513

Entity Name

JIANGSU HUAYUAN MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Dongtai Jiangsu, CN

Establishment Address

No.36 Nanzhuang Road, High-Tech Industrial Development Zone of, Dongtai Jiangsu 224200, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Jiangsu Huayuan Medical Technology Co., Ltd. (Owner Number: 10059981)

Owner / Operator Contact Address

No.36 Nanzhuang Road, High-Tech Industrial Development Zone of, Dongtai, CN-JS 224200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102362

PMA Number

N/A

All Registered Proprietary Names

Vinyl Patient Examination Gloves

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2019-03-17

Official Correspondent

Yun Gao

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Jiangsu Huayuan 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
K052612	Shanghai Antares Industries, Inc.	DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR	2005-11-22
K120584	Wealth on (Jiangsu) Co., Ltd.	POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES	2012-07-10
K220992	Ever Global (Vietnam) Enterprise Corporation	Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple	2022-10-19
K112610	Inpro Technology Device Factory	SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)	2011-12-05
K131340	Made Plastic Co., Ltd.	POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES	2014-09-09

Similar Registrations

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3012317628	ZIBO LING YUN MEDICAL PRODUCTS CO., LTD.	Zibo Shandong, CN
3015477649	SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD	HEZE CITY Shandong, CN
3006789222	Xuzhou Full Sun Medical Products Ltd.	Pizhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012304513. Last updated year: 2026. Please use registration number 3012304513 when referencing this establishment in official correspondence.