Data / Medical devices / China / Makrite Hubei Industrial Co., Ltd.
Makrite Hubei Industrial Co., Ltd.: FDA-registered device maker in Chibi High-Tech Zone Hubei, China, 5 510(k) clearances
Makrite Hubei Industrial Co., Ltd. is registered with the FDA (registration 3017168988) in Chibi High-Tech Zone Hubei, China. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 5, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017168988
- Address
- No. 1, Zhonger Street Guang Gu Industrial Park, Chibi High-Tech Zone Hubei, China, --
- Owner or operator
- Makrite Industries Inc. (8043227)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 11, 1999
- Registered through
- 2026
- Brand names listed
- 9500-N95, 9500-N95S, 910-N95FMX, Disposable Medical Face Mask (M643BE), 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 (S643BE, S643BEF, S643BT, S643BTF), Disposable Medical Face Mask (S653BE, S653KE, S653BEF, S653KEF, S653BT, S653BTF), Disposable Medical Face Mask (S663BE, S663BEF, S663BT, S663BTF) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 5, 2026 | K252650 | Disposable Medical Face Mask | FXX | Substantially Equivalent | Makrite Industries, Inc. | accessdata.fda.gov |
| April 18, 2024 | K240258 | Disposable Medical Face Mask (M643BE) | FXX | Substantially Equivalent | Makrite Industries, Inc. | accessdata.fda.gov |
| June 14, 2022 | K220550 | Disposable Surgical Face Mask (M663BE, M663BT) | FXX | Substantially Equivalent | Makrite Industries, Inc. | accessdata.fda.gov |
| July 23, 2002 | K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 | MSH | Substantially Equivalent | Makrite Industries, Inc. | accessdata.fda.gov |
| November 3, 1989 | K895077 | SURGICAL MASK/DENTAL MASK | FXX | Substantially Equivalent | Ashton Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Respirator, Surgical
- All makers of Accessory, Surgical Apparel
Updated January 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.