Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013576504

FEI Number

3013576504

Entity Name

ZIBO CHENGXUN AUTOMATIC DEVICE CO., LTD

City/State/Country

Zibo Shandong, CN

Establishment Address

No. 37 Minan Road, High-tech Industrial,, Zibo Shandong 255086, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Zibo Chengxun Automatic Device Co., Ltd (Owner Number: 10053713)

Owner / Operator Contact Address

No. 37 Minan Road, High-tech Industrial,, Zibo, CN-SD 255086, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222815

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
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2017-01-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-05-10
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-04-02
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-04-02
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2024-04-02
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-04-02

Official Correspondent

Wei Ding

US Agent Details

Ken Li Business: Omni International Corp Email: like@bluesail.cn Phone: (603) 4711499

Related Public Records

Same Entity

Zibo Chengxun Automatic Device 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

Registration Number	Establishment Name	Location
3020106122	BINH AN MEDICAL CO., LTD	Dong Trieu Township, Quang Ninh, VN
3017940518	STAR INVESTMENT AND TRADE JOINT STOCK COMPANY	Bac Ninh, VN
3012304513	JIANGSU HUAYUAN MEDICAL TECHNOLOGY CO., LTD.	Dongtai Jiangsu, CN
3012317628	ZIBO LING YUN MEDICAL PRODUCTS CO., LTD.	Zibo Shandong, CN
3015477649	SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD	HEZE CITY Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013576504. Last updated year: 2026. Please use registration number 3013576504 when referencing this establishment in official correspondence.