Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017270814

FEI Number

3017270814

Entity Name

ZHANGJIAGANG BITOOR CO., LTD

City/State/Country

ZHANGJIAGANG Jiangsu, CN

Establishment Address

CHANGJING DONG ROAD, YANGSHE TOWN, ZHANGJIAGANG Jiangsu 215600, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

ZHANGJIAGANG BITOOR CO., LTD (Owner Number: 10081804)

Owner / Operator Contact Address

CHANGJING DONG ROAD, YANGSHE TOWN, ZHANGJIAGANG, CN-JS 215600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable TPE gloves, Poly gloves, Stretch gloves bouffant non-woven cap Dental chair plastic headrest cover, Disposable dental chair plastic bag, Disposable headrest cover, Disposable bag Countway bag; Sponge; Surgical; Counter CPE Gown Isolation Gown Non-surgical Isolation Gown CPE APRON with sleeves

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QLB	N/A	N/A	Class N/A	N/A	2021-05-17
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2024-03-24
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2021-05-18
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2021-05-18
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2021-05-17

Official Correspondent

Jay Di

US Agent Details

Mark Gordon Email: Mark.W.Gordon@outlook.com Phone: (571) 4072862

Related Public Records

Same Entity

ZHANGJIAGANG BITOOR CO., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017270814. Last updated year: 2026. Please use registration number 3017270814 when referencing this establishment in official correspondence.