Disposable Medical Hospital Mask - FDA Certified "
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FDA Class I (General Controls) disposable medical masks. Made in a FDA Certified Medical Factory.
If the intended use is for a Hospital, please verify with your hospital buyer before placing the order.
FDA product code: LYU https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2862
Regulation number: 878.4040 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRsearch.cfm?FR=878.4040
Submission Type: 510(K) Exempt
Device Class: 1
Standard: EN 14683:2019+AC: 2019 except for clause 5.2.6
A pleated 3 layer design, the filter reaches efficiencies over 99%. Soft lined, water-resistant material with an adjustable nose piece & ear-loop provides convenience and comfort.
Size: 7" X 3.55"
Materials: Non-Woven Polypropylene
Imprint Method: Sold Blank
Price Includes: Blank masks
Setup fee (G): 0.0
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