Surgical Face Masks

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FDA 510(k) – ASTM Level 3 – Made in the USA

Professional Surgical Mask - Made in the USA

Important Documents:

Fast Facts

  • Item: ASTM Level 3 Surgical
  • Style: Ear Loop Surgical, Premium Grade
  • Standard: ASTM F2100-19
  • FDA 510(k): K211861
  • FDA Listing Number: D455620

Description

  • Outer Fabric: 23 GSM Premium Spun Bond Polypropylene
  • Filtration Layer: TMS Meltblown 97+ PFE Polypropylene
  • Nose Bridge: 3mm Polyethylene Coated Wire
  • Color: White/Blue
  • Earloop: 3mm Nylon/Spandex
  • Size: Adult 175mm x 95mm, 3.0-3.2g/piece

ASTM F-2100-19 Testing Protocol

TestStandardResults
PFEASTM F2299STD ≥98%
TMS >99.981%
BFEASTM F2101-19, EN 14683:2019STD ≥98%
TMS >99.9%
Differential PressureEN14683:2019 Annex C, ASTM F2100-19<6.0 mm H2O/cm2
Blood PenetrationASTM F1862, ISO 22609 160mm/Hg Level 3
Flammability21 CFR 1610Class I
Skin SensitizationISO 10993-10Non-Sensititizing
Skin IrritationISO 10993-10Non-Irritating

Packaging

  • GTIN – Unit: 00860007355943
  • GTIN – Packaged Unit: 00860007355950
  • GTIN – Case: 10860007355902
  • Package: 50 pieces/box, 40 boxes/carton
  • Box Size: 8in x 4in x 4in  |  20cm x 10cm x 10cm
  • Carton Size: 22-1/2in x 17in x 16-1/2in
  • Carton Cube: Cube 3.463ft |  0.098m3
  • G.W.: 20.1 Lbs
  • N.W.: 19.4 Lbs
  • Pallet Dimensions: 52in x 46in
  • TiHi – 92in H: 6 x 5  |  74in H: 6 x 4
  • Shipping Weight – 92in H: 630  |  74in H: 530
Professional Surgical Mask - used by surgeon
Made in the USA
Made in North Carolina
Professional Surgical Mask - shipped by the pallet
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