
FDA 510(k) – ASTM Level 3 – 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
Test | Standard | Results |
---|---|---|
PFE | ASTM F2299 | STD ≥98% TMS >99.981% |
BFE | ASTM F2101-19, EN 14683:2019 | STD ≥98% TMS >99.9% |
Differential Pressure | EN14683:2019 Annex C, ASTM F2100-19 | <6.0 mm H2O/cm2 |
Blood Penetration | ASTM F1862, ISO 22609 | 160mm/Hg Level 3 |
Flammability | 21 CFR 1610 | Class I |
Skin Sensitization | ISO 10993-10 | Non-Sensititizing |
Skin Irritation | ISO 10993-10 | Non-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 3.463ft3 | 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







