China Hubei Orient International Corporation latest company news about FDA ASTM F2100 Level-3 Disposable Surgical Face Mask

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FDA ASTM F2100 Level-3 Disposable Surgical Face Mask

June 24, 2024

Intended Use:

The Medial Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body

fluids and particulate material. They are intended for use in infection control practices to reduce the potential exposure to blood and body

fluids. This is a single use, disposable device(s), provided non-sterile.

Test Data:

Manufacturer	Ammex-Weida (Hubei) Health and Safety Products Co., Ltd
510K number	K211062
Device	medical face mask
Model	earloop, flat pleates, 3 layers
Sterility	non-sterile
Use	disposable, single use
ASTM F2100 Level	level-3
Biocompatibility	ISO10993
Fluid Resistance Performance ASTM F1862	32 out of 32 pass at 160 mmHg
Particulate Filtration Efficiency ASTM F2299	98.98%
Bacterial Filtration Efficiency ASTM F2101	99.9%
Differential Pressure (Delta P) EN 14683 Annex C	5.54mmH₂O/cm²
Flammability 16 CFR 1610	Class 1

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