Acme Filter Mask, Inc.
TW Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
FDA establishments
- Acme Filter Mask Inc. New Taipei City · TW FEI 3007053183
What Acme Filter Mask, Inc. makes
Acme Filter Mask, Inc. manufactures surgical face masks, including the ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P, designed for use in medical and surgical settings to reduce airborne contamination.
The company’s products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Acme Filter Mask, Inc. manufacture?
Acme Filter Mask, Inc. specializes in surgical face masks, such as the ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P. These devices are intended for use in medical and surgical environments to help reduce airborne contamination during procedures.
Where is Acme Filter Mask, Inc. based?
Acme Filter Mask, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, as it operates within the FDA’s jurisdiction.
How are Acme Filter Mask, Inc.’s devices classified under FDA regulations?
Acme Filter Mask, Inc.’s devices, including surgical face masks, are classified as Class II medical devices by the FDA. This classification requires pre-market notification (510(k)) clearance, as these products pose moderate risk and require general controls plus special controls to ensure safety and effectiveness.
Are Acme Filter Mask, Inc.’s devices listed in any regulatory registries?
Yes, Acme Filter Mask, Inc.’s devices are listed in the FDA’s 510(k) database. This registry includes products that have undergone the required pre-market notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring compliance with FDA regulations.
Information
- Country
- TW