Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017168988

FEI Number

3017168988

Entity Name

Makrite Hubei Industrial Co., Ltd.

City/State/Country

Chibi High-Tech Zone Hubei, CN

Establishment Address

No. 1, Zhonger Street, Guang Gu Industrial Park, Chibi High-Tech Zone Hubei --, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Makrite Industries Inc. (Owner Number: 8043227)

Owner / Operator Contact Address

11F-5., No.79, Sec.1, Xintai 5th Rd., Xizhi Dist.,, New Taipei City, TW-NWT 221, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220550

PMA Number

N/A

All Registered Proprietary Names

Halyard FIT+4803, 9603, 9603S Makrite Grainger International Inc. AKA Grainger Global Sourcing HEALTHCARE RESPIRAT HEALCARE RESPIRATO Disposable Medical Face Mask (M643BE) Disposable Surgical Face Mask (M663BE, M663BT)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	1999-02-11
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-08-09
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2006-12-21
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-04-24
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-06-16

Official Correspondent

Cynthia Shih

US Agent Details

Legrand Lindor Business: Makrite North America Email: Legrand@makritenorthamerica.com Phone: (855) 5648398

Related Public Records

Same Entity

Makrite Industries Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017952635	Makrite Industrial (Thailand) CO., LTD.	SI RACHA Chon Buri, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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3017598017	DURIO PPE SDN. BHD.	Johor Bahru, MY
3002813051	IRIS USA INC	Pleasant Prairie, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017168988. Last updated year: 2026. Please use registration number 3017168988 when referencing this establishment in official correspondence.