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A The FDA regulates face masks, including cloth face coverings, and surgical masks as medical devices when they are marketed for medical purposes. Medical purposes include uses related to COVID Nanjing Sealand Medical with Ce FDA maskKN95 5 Layers KN95 Respirator Face Mask 10 Pack (Ships Nanjing Sealand Medical with Ce FDA mask50 Pack KN95 5 Layers KN95 Respirator Face Mask FDA Certified and CE Approved KN95 Face Respirator Mask. This KN95 protective mask effectively filters non-oily particles to serve as barrier to potential air pollutants that can be harmful. The face masks filtration efficiency of 5 layers will help block out PM2.5 air pManufacturers, Suppliers, Exporters , was established in 2005, and our plant locates in Nanjing Economic Development Zone which is in the west of the famous Nanjing Qi Xia Mountain scenic area. Nanjing Economic Development Zone is close to Nanjing Port, Shanghai-Nanjing Highway, which enable our plant to transport quickly and conveniently.
Medical masks may also be used to help reduce the risk of splashes or sprays of blood, body fluids, secretions, and excretions from reaching the wearers mouth and nose. Medical masks are a barrier to splashes, droplets, and spit and may also Product Classification - Food and Drug AdministrationFeb 01, 202110903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDARecognized Consensus Standards - Food and Drug AdministrationDec 21, ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) Scope/Abstract 1.1 This test method is used to evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream Nanjing Sealand Medical with Ce FDA mask
Dec 29, 20143H Medical is ISO 9001(2000), ISO 13485 certified, and can use the CE mark, also had got FDA registration number in USA. The company focus on new technology innovation and new material to update the level of quality and reasonable prices.
Non Sterile Surgical Face Mask CE Marking and EU Registration is mandatory for marketing the medical device in the European region. The present European Medical Device Directive (MDD) has to be followed with regard to Class 1 medical devices.. Since it falls under Class 1, Non-Sterile Surgical Mask can be self Certified as per MDD 93/42/EEC.