MSC export restrictions on certain types of personal protective equipment products

There has been an extension to the order making it applicable for another 120 day and  due to the evolution of the COVID situation more has been added to the list.

The rules now cover the below 17 types of PPE:

1. N–95 Filtering Facepiece Respirators, including devices that are disposable half-face-piece non-powered airpurifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates

2. Other Filtering Facepiece Respirators (e.g., those designated as N99, N100, R95, R99, R100, or P95, P99, P100), including single-use, disposable halfmask respiratory protective devices that cover the user’s airway (nose and mouth) and offer protection from particulate materials at an N95 filtration efficiency level per 42 CFR 84.181

3. Elastomeric, air-purifying respirators and appropriate particulate filters/ cartridges

4. Powered Air Purifying Respirator (PAPR)

5. Portable Ventilators, including portable devices intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas

6. Sterilization services for any device including devices that already have FDA marketing authorization and those that do not have FDA marketing authorization but are intended for the same uses

7. Disinfecting devices intended to kill pathogens and other kinds of microorganisms by chemical means or physical means and other sanitizing and disinfecting products suitable for use in a clinical setting

8. Medical gowns or apparel, e.g., surgical gowns or isolation gowns

9. Personal protective equipment (PPE) coveralls, e.g., Tyvek Suits

10. PPE face masks, including any masks that cover the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels

11. PPE surgical masks, including masks that covers the user’s nose and mouth and provides a physical barrier to fluids and particulate materials

12. PPE face shields

13. PPE gloves or surgical gloves, (exam gloves), (surgical gloves) and such gloves intended for the same purposes

14. Ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as ‘‘ventilators’’), ventilator tubing connectors, and ventilator accessories

15. Laboratory reagents and materials used for isolation of viral genetic material and testing, such as transport media, collection swabs, test kits and reagents specific to those kits, and consumables such as plastic pipette tips and plastic tubes

16. Drug products currently recommended by the NIH COVID–19 Treatment Guidelines Panel, including (as of July 23, 2020) remdesivir and dexamethasone

17. Alcohol-based hand sanitizer and rubs