Supply Hawk has partnered with Skypro Medical to deliver fully ASTM Level 2 compliant masks. These masks are fully certified and are classified under the FDA's FXX product code. 510K is available here.
Protection you can trust. Tested in the US. Intended for use by medical professionals and the public. Manufactured since 2016.
- ASTM 1862 Fluid Resistance Level 2 (120 mmHg)
- 16 CFR 1610 Class I Flammability Requirement
- PFE ≥ 98%, BFE ≥ 98%
- FDA 510K acknowledgement available here from August of 2016
- Produced by an FDA registered manufacturer certified to manufacture many types of medical supplies, not just masks
- Materials: Sonically bonded spunbond polypropylene, meltblown polypropylene, and spunbond polypropylene. Tyrelene and spandex earloops.
- Single use only.
- 50 masks per box.
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