FAQ

PRODUCT CONFORMITY

  1. What does it mean that your surgical mask is 510(k)-cleared by FDA?
  2. What types of masks are distributed under FDA’s enforcement policy and what is an enforcement policy?
  3. What is the difference between a face mask and a surgical mask?
  4. Please see detailed product information on the BYD care official website:

PRODUCT STANDARD

  1. What are the applicable performance standards for surgical masks?
  2. What are N95 respirators?

FACE FITTING

  1. Please visit the BYD CARE website for instructions and information on how to properly wear the masks.

PRODUCT CONFORMITY

  1. What does it mean that your surgical mask is 510(k)-cleared by FDA?

    A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. We received 510(k) clearance for a single use surgical mask and are distributing the following models under the 510(k):

    Surgical Face Mask Model# FE2311 Level III
    Surgical Face Mask Model# FE2811 Level III
  2. What types of masks are distributed under FDA’s enforcement policy and what is an enforcement policy?


    FDA issues enforcement policies to notify the public of its intent to not enforce certain regulatory requirements that would otherwise apply. FDA issued a number of enforcement policies during the pandemic. For example, FDA issued an enforcement policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for healthcare personnel during the COVID-19 public health emergency. This policy remains in effect for the duration of the COVID-19 public health emergency:
    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-respirators-during-coronavirus-disease-covid-19-public-health

    We are marketing the following masks under the enforcement policy:
    Flat Surgical Face Mask Model# FE2311 Level II
    Flat Surgical Face Mask Model# FE2311X Level III
    Flat Face Mask Model# Costco Face Mask
    Flat Face Mask Model# FE2211-Face Mask
    Flat Face Mask Model# FE2411 BLUE
    Flat Face Mask Model# FE2411 PINK
    Flat Face Mask Model# FLAT Single Use Face Mask
    Flat Face Mask Model# FE2411 Option 1-Pattern
    Flat Face Mask Model# FE2411 Option 2-Pattern

  3. What is the difference between a face mask and a surgical mask?


    A face mask covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. Face masks may be used by the general public and health care personnel as source control, to cover the mouth and nose to contain that individual’s respiratory secretions to help prevent transmission from infected individuals.

    A surgical mask covers the user’s nose and mouth and provides a physical barrier to fluids and particulate material. Unlike a face mask, a surgical mask must meet certain fluid barrier protection standards and Class I or Class II flammability tests.
    For more information, please see:
    https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/face-masks-including-surgical-masks-and-respirators-covid-19

  4. Please see detailed product information on the BYD care official website:

    https://www.byd.care/


    PRODUCT STANDARD

    1. What are the applicable performance standards for surgical masks?
      1. ASTM F2100 standard table

        Source link:
        https://www.astm.org/DATABASE.CART/HISTORICAL/F2100-19.htm

      2.  EN 14689 2019 standard table 

        Source link:
        https://standards.cen.eu/dyn/www/f?p=204:110:0::::FSP_PROJECT:69675&cs=1956C06A1BAF887FF462DD56057D34F29

    2. What are N95 respirators?
      1. A N95 respirator is a particulate filtering facepiece respirator that filters at least 95% of airborne particles but is not resistant to oil. For more information, please see:


        https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource3basic.html

      2. Link for BYD precision mask product link 


        https://www.byd.care/pages/n95-respirator


    FACE FITTING

    1. Please visit the BYD CARE website for instructions and information on how to properly wear the masks.


      Add link to the video or YouTube link
      https://www.youtube.com/watch?v=Lm7KwYp9DXY&feature=emb_rel_pause

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