Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
General Hospital · 21 CFR 880.6260
It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.
Recent MDR events
4 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Whirlpool CorporationTerminatedUnknown
PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1
The rivets that secure the elastic headband to the face shield have the potential to be mis-assembled. When this condition occurs, it can result in a headband that can become loose from face shield allowing the face shield to shield on the user.
Z-2815-2020 · View FDA record ↗ - Office Depot IncOpen, ClassifiedUnknown
JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces
Test results revealed that the KN95 masks failed to filter greater than 95% of particulates.
Z-3024-2020 · View FDA record ↗
Registered firms
12 firms currently registered for this product code
Katmai Integrated Solutions
Brilliant, OH, US
3m Company
Saint Paul, MN, US
Xiantao Sanda Industrial Co., Ltd
Xiantao Hubei, CN
Chengde Technology Co., Ltd
Longgang Zhejiang, CN
Pasture Pharma Pte Ltd
Corporation Place Central Singapore, SG
Wenzhou Sanshan Optics Co., Ltd.
WENZHOU Zhejiang, CN
Katmai Health Services Llc
Brilliant, OH, US
Hydrochem Co., Ltd
Gangeung-Si Gangwon, KR
An Lanh Investment And Trading Company Limited
Thanh Nam Ward Ninh Binh, VN
Shenzhen Mondial Technology Co., Ltd.
Shenzhen Guangdong, CN
Szy Holdings Llc.
BROOKLYN, NY, US
Xiantao Zhongyi Safety & Protection Products Co.,ltd.
Xiantao City Hubei, CN
510(k) clearances
2 clearances for this product code