Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008062466

FEI Number

3008062466

Entity Name

Suzhou Colour-way New Material Co., Ltd.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No. 20, Anmin Road, Huangdai Town, Xiangcheng District, Suzhou Jiangsu 215152, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Suzhou Colour-way New Material Co., Ltd. (Owner Number: 10030755)

Owner / Operator Contact Address

No. 20, Anmin Road, Huangdai Town, Xiangcheng District, Suzhou, CN-JS 215152, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterilized Latex Surgical Gloves Radiation protection cap, Thyroid collar Radiation protection sleeve Jass Duro, m. Dior, S Shock Shark Condoms Jass Duro, Male Latex Condoms Powdered Latex Surgeon's Glove Radiation Protection Gloves

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-04-07
IWO	Apron, Protective	Radiology	Class 1	892.6500	2023-04-13
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2023-12-13
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2009-11-08
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2023-04-07
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-09-11
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2018-10-09

Official Correspondent

Lingling Yu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Suzhou Colour-way New Material 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
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008062466. Last updated year: 2026. Please use registration number 3008062466 when referencing this establishment in official correspondence.