Data / Medical devices / Taiwan / Acme Filter Mask Inc.
Acme Filter Mask Inc.: FDA-registered device maker in New Taipei City, Taiwan, 1 510(k) clearance
Acme Filter Mask Inc. is registered with the FDA (registration 3007053183) in New Taipei City, Taiwan. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 20, 2013. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007053183
- Address
- No.57, Hu Shan Rd. Yi Ko Town, New Taipei City, Taiwan, 23941
- Owner or operator
- ACME Filter Mask Inc. (10030786)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 10, 2020
- Registered through
- 2026
- Brand names listed
- Face Mask (Except N95 Respirator), Face Shield, Surgical Mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| May 20, 2013 | K123115 | ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P | FXX | Substantially Equivalent | Acme Filter Mask, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Mask, Surgical
- All makers of Accessory, Surgical Apparel
Updated May 20, 2013. 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.