One face mask, which is with ASTM LEVEL 3 test reports, may have 3 types:
1) Strictly speaking, a Medical (or Procedure / Surgical) face mask, must satisfy three conditions, at the same time.
with 510K number on FDA with FXX product code on FDA with ASTM Level 1/2/3 test reports
2) During COVID-19 period,there are one type of Medical face mask permitted by FDA,
without 510K number without FXX product code with ASTM Level 1/2/3 test reports with QKR product code on FDA with limited product label contents ( at least no liquid barrier info)
Remark: this type is a little complicated on the product packing label.
3) Non-medical (general use) 3-ply face mask
Because the 510K number and FXX(or QKR)-product-code are in the process(not valid at this moment), and ONLY with Nelson test report,we use it as a non-medical item.