On March 2, 2020, in a joint effort, the U.S.Food and Drug Administration and the Centers for Disease Control and Preventiontook action to make more respirators, including certain N95s, available tohealth care personnel. Currently, the majority of respirators on the market areindicated for use in industrial settings. Today¡¯s action allows certainNational Institute for Occupational Safety and Health (NIOSH) approvedrespirators not regulated by the FDA to be used in a health care setting duringthe coronavirus (COVID-19) outbreak, thereby maximizing the number ofrespirators available to meet the needs of the U.S. health care system.
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In the meantime, the FDA issued an Emergency UseAuthorization (EUA) for emergency use of, (1) all disposable filteringfacepiece respirators (FFRs) approved by the National Institute forOccupational Safety and Health (NIOSH), in accordance with 42 CFR Part 84, asnon-powered air-purifying particulate FFRs, and (2) FFRs that wereNIOSH-approved but have since passed the manufacturers' recommended shelf-life,for use in healthcare settings by healthcare personnel (HCP) to prevent wearerexposure to pathogenic biological airborne particulates during FFR shortagesresulting from the Coronavirus Disease 2019 (COVID-19) outbreak.
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U.S. FDA has provided a list for approved holder as below:
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3M Company
Moldex-Metric, Inc.
Honeywell International Inc.
Louis M. Gerson Company, Inc.
Honeywell Int¡¯l. Inc.
Mine Safety Appliances Company
Kimberly-Clark Corporation
O&M Halyard, Inc.
Prestige Ameritech
Dentec Safety Specialists Corp.
Alpha Pro-Tech
Makrite Industries, Inc.
Dr?ger Safety AG & Co. KGaA
Jahan Company t/a IREMA Ireland
Industrias Saver
KOS Protecci¨®n S.A.S
Japan Vilene
Koken, Ltd.
San M Package Co., Ltd.
Shigematsu Works Co., Ltd.
M/s. Magnum Health & Safety Pvt. Ltd.
Venus Safety & Health Pvt., Ltd.
Dobu Life Tech Co. Ltd.
Ever Green Co., Ltd.
Profit Royal Pharmaceutical Ltd.
Aero Pro Co., Ltd
AOK Tooling Limited
Aswan International Corp.
Champak Enterprise Co., Ltd.
Fido Mask Company
Guangzhou Harley Commodity Company Limited
Innonix Technologies Limited
Jinfuyu Industrial Co., Ltd.
Master & Frank Ent. Co. Ltd.
Rizhao Sanqi Medical & Health Articles Co., Ltd.
San Huei United Company, Ltd.
Shanghai Dasheng Health Products Manufacture Co., Ltd.
Shanghai Gangkai Purifying Products Co., Ltd.
Shining Star Electronic Technology Co., Ltd
Suzhou Fangtian Industries Co., Ltd.
Suzhou Sanical Protective Product Manufacturing Co., Ltd.
XiantaoZhongyi Safety Protection Products Co., Ltd.
Paul Boye, Inc
Global Safety First
NITTA Corp. S.A.