Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- OWPBiological Sterilization Process Indicator With Recombinant-Dna Plasmid2Product Code
- LLCContainer, Supplementary NitroglycerinUProduct Code
- LLDPort & Catheter, Implanted, Subcutaneous, IntraperitonealUProduct Code
- LMQDevice, Peritoneal Access, Subcutaneous, Implanted3Product Code
- LNXMedical Computers And SoftwareUProduct Code
- LNYCatheter, Percutaneous, Long Term, Intraspinal3Product Code
- LPZContainer, Frozen Donor Tissue StorageUProduct Code
- LSXController, Closed-Loop, Blood-Pressure3Product Code
- QKYDecontamination Systems For N95 RespiratorsNProduct Code
- LDHSystem, Delivery, Allergen And VaccineUProduct Code
- LKBPad, Alcohol, Device DisinfectantUProduct Code
- LKKPump, Infusion, Implanted, Programmable3Product Code
- LWEBone Marrow Collection/Transfusion Kit2Product Code
- MQTPump, Drug Administration, Closed Loop3Product Code
- NSXSoftware, Transmission And Storage, Patient DataUProduct Code
- PGOAnti-Stick Glass SyringeNProduct Code
- POTLockbox (Export Only)NProduct Code
- PWCGeneral Wellness ProductUProduct Code
- QBPCap, Device DisinfectantUProduct Code
- QIXSystem, Transdermal Delivery, Cder Or Cber LedNProduct Code
- QIYNasal Spray, Systemic Delivery, Cder Or Cber LedNProduct Code
- QIZMaterial, Implantable For Controlled Release, Cder Or Cber LedNProduct Code
- QKRFace Mask Per Enforcement Policy For Face Masks And Respirators During The Declared Public Health EmergencyNProduct Code
- QKUNon-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)NProduct Code
- QLDProtective Barrier EnclosureNProduct Code
- QLEProtective Barrier Enclosure With Negative PressureNProduct Code
- QMFMask, Surgical, Eua AuthorizedNProduct Code
- QOZBarrier Face Covering Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health EmergencyNProduct Code
- QJTRigid Sterilization Container With Software2Product Code
- QTGInfant Supine Sleep System2Product Code
- QWSFoam Or Gel Chemical Sterilant/High Level Disinfectant2Product Code
- QWXActive Noise Attenuation System For Infant Incubators2Product Code
- QXJWhole Room Microbial Reduction Device2Product Code
- QZABody Temperature Sensing Software2Product Code
- QPKEua FaceshieldsNProduct Code
- QZTGowns And Other ApparelNProduct Code
- SBEDigital Physical/Chemical Sterilization Process Sensor2Product Code
- QVBBiological Sterilization Indicator With Indirect Growth Detection2Product Code
- QXQRespiratory Accessory Microbial Reduction Device.2Product Code
- SCSUltraviolet Radiation Disinfection Chamber Device2Product Code
- SDCQualitative Cleaning Process Protein Indicator2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Face Mask Per Enforcement Policy For Face Masks And Respirators During The Declared Public Health Emergency
- Page Type
- Product Code
- Definition
- Face mask is intended to be worn by general public or healthcare personnel and excludes air purifying respirators. The mask covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. The device is either subject to the Enforcement Policy for Face Masks, Surgical Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-respirators-during-coronavirus-disease-covid-19-public-health, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance, or to the Face Mask Umbrella EUA, available at https://www.fda.gov/media/137121/download.
- Physical State
- Solid materials.
- Technical Method
- Physical barrier to materials.
- Target Area
- Nose and mouth
- Review Panel
- General Hospital
- Submission Type
- Enforcement Discretion
- Device Classification
- N
- GMP Exempt?
- Yes
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
As product code QKR is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.