ISO14644 Custom Earloop Disposable Medical Face Masks 50pcs

Disposable Surgical Mask For Adult With Ear Loop

Sepcification

50 pieces per box (Bulk Pack)

Size: 17.5 x 9.5cm

Color: Sky Blue

ASTM F2100 Level 3 EN14683 Type IIR

Bacterial Filtration Efficiency (BFE) ≧99%

Sub-micron Particulate Filtration Efficiency (PFE) ≧99%

Production Clean Room certified by ISO14644 Class 8

ISO 13485:2016 Certified

Others

This page provides information on face masks, barrier face coverings, surgical masks, and respirators (filtering facepiece respirators, such as N95 respirators) intended for a medical purpose to assist in preventing the spread of infectious materials during the COVID-19 pandemic.

This page does not cover:

Powered respirators, such as powered air purifying respirators (PAPRs)

Face shields

Non-healthcare use of face masks and respirators intended to limit industrial or general exposure to non-infectious particles, such as during construction or other industrial use.

The information provided may be useful to manufacturers and importers of face masks, barrier face coverings, surgical masks, and respirators, as well as health care facilities and health care personnel.

To help expand the availability of face masks, barrier face coverings, surgical masks, and respirators, the FDA is providing certain regulatory flexibility for the duration of the COVID-19 public health emergency, as described in the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised), and has issued emergency use authorizations (EUAs) for face masks, surgical masks, and respirators that meet certain criteria. The FDA regularly updates its communications about face masks, surgical masks, and respirators, including the answers to frequently asked questions on this page.