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Which KN95 Masks Are Approved?

In the last few weeks, the US stance on imported respiratory facemasks has changed. To ensure medical staff have the equipment they need to combat Covid-19, Chinese manufactured masks will now be permitted. This policy reversal primarily refers to the KN95 mask, a facemask with near identical properties to the American N95 mask.

Despite the reversal, there are still questions being asked about the KN95 facemask and its ability to protect medical workers. To reiterate, the FDA has deemed these masks suitable and safe for use in the absence of normal N95 supplies. While KN95 masks reportedly fit looser, the lowest protection rating they have received is 89.9%.

This is still miles ahead of a surgical facemask made from paper. So, the FDA is recommending doctors and nurses switch to KN95 masks once their regular supplies are depleted. Let’s take a closer look at what this means for hospitals.

Can Facemasks from Overseas Be Trusted?

The FDA should be your guide on this whether you’re a hospital worker or a citizen who’s worried about catching the virus. If the FDA has approved a foreign made facemask, it has done so because it believes the item to be safe and reliable. This is the case for KN95 facemasks from China though they are not NIOSH approved.

It also includes non-NIOSH approved respiratory masks imported from Australia, Brazil, Korea, Japan, Mexico and most of Europe. All are suitable for use in American hospitals provided the products have been tested and approved ‘in country’ to a similar standard outlined by NOISH. These countries must be able to demonstrate adherence to equivalent standards.

Due to the unprecedented nature of the Covid-19 outbreak, KN95 facemasks and other imported supplies may be acquired without an EUA (for the time being). Where this is the case, importers are asked to take steps to validate the legitimacy of supplies. Where appropriate, the FDA is expediting imports of protective equipment, however, quality control checks are ongoing.

Importers are asked to use the following contact address to ensure requests and concerns are handled as promptly as possible: covid19fdimportinquiries@fda.hhs.gov.

The following KN95 masks are approved and suitable for use in medical settings:

KN95 (AAB China Co. Ltd.)

KN95 Particulate Respirator (Allmed)

BYD KN95 Particulate Respirator (BYD Precision Manufacture Co. Ltd.)

KN95 (PM 2.5) Protective Mask (Chengde Technology Co.)

KN95 (Changzhou WeDream Medical Device. Ltd.)

KN95 ZN6005 (Chongqing China Nano Technology Co. Ltd)

Langie KN95 FFP2 (Chuzhou Qiao Dong Industrial Co. Ltd.)

KN95 (CTT Co. Ltd.)

KN95 FFP2 (DaddyBaby Co. Ltd.)

KN95 N9 (Dongguan Arun Industrial Co. Ltd).

KN95-A/KN95-B (DongGuan HyaGuang Communication Technology Co. Ltd.)

LH-KN95 (Dongguan Leihuo Medical Device Co. Ltd.)

KN95 (Dongguan Sengtor Plastics Products Co. Ltd.)

KN95 (Dongguan Xianda Medical Equipment Co. Ltd.)

KN95 Model 9051A (Foshan Nanhai Weijian Sanbang Protective Equipment Technology)

KN95 (Fujian Kang Chen Daily Necessities Co. Ltd.)

KN95 (Guangdong Fei Fan MStar Technology Ltd.)

8862 KN95 (Guangdong Golden Leaves Technology Development Co., Ltd)

KN95 (Guangdong Nuokang Medical Technology Co., Ltd.)

Is It Safe to Use Expired KN95 Facemasks?

In normal circumstances, this would not be permitted. However, the FDA has determined expired facemasks (of an appropriate standard) do still provide sufficient protective in most cases. Regardless, this option should be viewed as a last resort. If imported supplies are expired, the manufacturer must make this clear at the point of sale.

The buyer must rigorously inspect the expired supplies before distribution and use. Any facemask with tears, holes or degraded material must be discarded or used for training purposes only.

The expiry date for a KN95 mask can be found on its label. If, for any reason, this is not the case, the manufacturer must provide accurate information.

The Final Word On KN95 Facemasks

The list of approved KN95 facemasks featured in this article is not exhaustive. For a comprehensive list, consult the FDA website. If the FDA has not approved a particular facemask, it should not be used in a medical setting. Currently, the guideline is for medical staff to continue using their regular N95 supplies and only switch to KN95 if these stocks become depleted.

The reuse of N95 and KN95 respiratory masks is permitted provided they are rigorously sterilized between uses. You are strongly advised to limit reuse to five occasions.