What does Makrite Hubei Industrial Co., Ltd. manufacture?

Registered with the FDA for 3 device types.

Is Makrite Hubei Industrial Co., Ltd. still registered with the FDA?

Yes. The registration is current and expires 2026.

Makrite Hubei Industrial Co., Ltd. → Supplier → Allomedo

Makrite Hubei Industrial Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Surgical, Respirator, Surgical and 1 other device type. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 1999.

3device types registered with the FDA

2products catalogued under its own name

Registration

FDA registration record for Makrite Hubei Industrial Co., Ltd.
Status	Registered
Registration expires	2026
Registration number	3017168988
FEI number	3017168988
DUNS	553815471
Establishment type	Contract manufacturer, Manufacturer

Chinese Registration

Chinese company register details for Makrite Hubei Industrial Co., Ltd.
Chinese legal name	知腾工业（湖北）有限公司
Unified social credit code	91421200MA491WCQ4U
Source	NMPA UDI database

Location

Address of Makrite Hubei Industrial Co., Ltd.
City	Chibi High-Tech Zone
Province	Hubei
Address	No. 1, Zhonger Street
Postal code	—
Country	China

Group

Makrite Hubei Industrial Co., Ltd. is one of 2 plants registered under Makrite Industries Inc..

Other plants under Makrite Industries Inc.
Plant	City	Device types
Dongguan Sure On Plastic and Fiber Product Co., Ltd.	Dong Guan	3

What It Makes

Device types Makrite Hubei Industrial Co., Ltd. is registered to make
Device type	Class	Listed under the names	Listed since	Chinese makers
Accessory, Surgical Apparel	Class 1	Ear Loop Mask	2017	439
Mask, Surgical	Class 2	Disposable Medical Face Mask (S663BE, S663BEF, S663BT, S663BTF), Disposable Medical Face Mask (S643BE, S643BEF, S643BT, S643BTF), Disposable Medical Face Mask (M643BEF, M643BT, M643BTF), Disposable Medical Face Mask (M653BE, M653KE, M653BEF, M653KEF, M653BT, M653BTF), Disposable Medical Face Mask (M663BEF, M663BTF), Disposable Medical Face Mask (S653BE, S653KE, S653BEF, S653KEF, S653BT, S653BTF) and 4 more	1999	125
Respirator, Surgical	Class 2	Healthcare Respirat, Healcare Respirato, Makrite, Grainger International Inc. AKA Grainger Global Sourcing, FIT+4803, 9603, 9603S	2006	118

Own-Brand Listings

Devices catalogued by Makrite Hubei Industrial Co., Ltd.
Product	Code	Catalogue numbers
Makrite Industries Inc.	MSH	7
Makrite Industries Inc.	FXX	2

Clearances

No clearance names Makrite Hubei Industrial Co., Ltd. as applicant. 5 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Makrite Hubei Industrial Co., Ltd. or its listings
Clearance	Decision date	Product code	Route	Held by
K252650	2026-01-05	FXX	Traditional	Makrite Industries, Inc.
K240258	2024-04-18	FXX	Traditional	Makrite Industries, Inc.
K220550	2022-06-14	FXX	Traditional	Makrite Industries, Inc.
K020474	2002-07-23	MSH	Traditional	Makrite Industries, Inc.
K895077	1989-11-03	FXX	Traditional	Ashton Medical Products, Inc.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Makrite Hubei Industrial Co., Ltd.
Founded	2017
Factory area	55,000 square meters (land), 30,000 square meters (building)
Main products	Industrial respiratory protection equipment, Medical respiratory protection equipment, Self-filtering particulate respirators, Disposable masks, Civil protection products
Export markets	Global (contributed to COVID-19 pandemic response)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Makrite Hubei Industrial Co., Ltd.