Medtecs Medical Mask
In compliance with FDA requirements. Designed to provide splash resistance in medical environments.
Features
- Obtained ASTM F2100-19 level 1*
- Disposable surgical mask for single use
- Elastic ear loops that do not contain rubber latex
- 3-ply polypropylene materials
- Dimensions: 17.5 cm x 9.3 cm
- Green
- Non-sterile
- Note: Based on the performance test result of 32 pcs x 3 non-continuous lots = 96 pcs total, which has been determined based on 4% AQL per ASTM F2100.
FDA Information
On May 21 2021, Medtecs Medical Mask has been authorized by the FDA under an EUA for use in healthcare settings by HCP as PPE to provide a physical barrier to liquids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during the COVID-19 pandemic.
This product is authorized only for the circumstances that justify the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
Regarding the current list of surgical masks authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency, please see Appendix A: FDA Authorized Surgical Masks
Medtecs Medical Mask Front
