Dongguan Sure on Plastic and Fiber Product Co., Ltd.
Registered establishment in Dong Guan, Guangdong, China. 3 device types.
Dongguan Sure On Plastic and Fiber Product Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Surgical, Respirator, Surgical and 1 other device type. Its earliest product listing with the FDA dates from 1999.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 9614598 |
| FEI number | 3003191210 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Dong Guan |
|---|---|
| Province | Guangdong |
| Address | BLDG. 2, CHU FO LING |
| Postal code | — |
| Country | China |
Group
Dongguan Sure On Plastic and Fiber Product Co., Ltd. is one of 2 plants registered under Makrite Industries Inc..
| Plant | City | Device types |
|---|---|---|
| Makrite Hubei Industrial Co., Ltd. | Chibi High-Tech Zone | 3 |
What It Makes
| 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 | Medline Face Mask, 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) and 4 more | 1999 | 125 |
| Respirator, Surgical | Class 2 | FIT+4803, 9603, 9603S, Healthcare Respirat, Healcare Respirato, Makrite, Grainger International Inc. AKA Grainger Global Sourcing | 2006 | 118 |
Clearances
No clearance names Dongguan Sure On Plastic and Fiber Product 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.
| 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.
| Main products | KN95 Protection Masks |
|---|
Nearby Manufacturers
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.