Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008191396

FEI Number

3008191396

Entity Name

Zibo Intco Medical Products Company Limited

City/State/Country

Zibo Shandong, CN

Establishment Address

18 Qingtian Road, Qilu Chem. Ind. Park,, Linzi, Zibo Shandong 255414, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zibo Intco Medical Products Company Limited (Owner Number: 10031179)

Owner / Operator Contact Address

18 Qingtian Road, Qilu Chem. Ind. Park, Linzi, Zibo, CN-SD 255414, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132201

PMA Number

N/A

All Registered Proprietary Names

Powder-Free Vinyl Patient Examination Gloves, Yellow Color Face Shields Isolation Gown Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue

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	2014-06-03
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2021-06-24
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-05-21
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2013-12-18

Official Correspondent

John Zhao

US Agent Details

Max Li Business: Primemax Email: maxli@basicmedical.com Phone: (909) 9801678

Related Public Records

Same Entity

Zibo Intco Medical Products Company Limited

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 3008191396. Last updated year: 2026. Please use registration number 3008191396 when referencing this establishment in official correspondence.