Bench Testing Required for Surgical Face Masks
The bench testing is a required section in 510k notification for surgical masks. It is performed on surgical mask to ensure the device design and construction are suitable for the intended use.
The following bench tests are required for surgical mask 510k submission.
- Fluid Resistance – Testing for resistance of surgical face masks to penetration by synthetic blood.
- Particulate Filtration Efficiency - To ensure the Particle filtration efficiency of materials used in facemask.
- Bacterial Filtration Efficiency – To evaluate the bacterial filtration efficiency (BFE) of medical face mask Materials.
- Differential Pressure – To determines the resistance of a surgical face mask to air flowing through it.
- Flammability – To evaluate the flammability of clothing textiles.
LMG Provide assistance to surgical masks manufacturers in FDA registration, 510k clearance, device listing and US FDA Agent requirements.
Our experienced consultants can help you to comply with FDA requirements. Our expertise includes
- Prepare 510k notification
- Submission of 510k notification
- FDA Agent service for 510k submission
- Guidance in test requirements
- Register your medical device establishment with FDA
- List your surgical mask with FDA.
FDA 510K Clearance are public information, you can verify clearance status at FDA site. Below are examples of surgical mask 510k clearance.