Personal Protection Kit
The Personal Protection Kit is a general hospital convenience kit containing personal protective equipment such as gloves, masks, gowns, and eye protection used by healthcare workers to protect themselves from exposure to infectious agents, chemical hazards, or body fluids during patient care activities. Product code PXC is established as a convenience kit under FDA's 1997 Convenience Kits Interim Regulatory Guidance and is under enforcement discretion, not requiring a 510(k) if all guidance criteria are met. It is classified as FDA Class I under regulation 21 CFR 880.6250, subject only to general controls. It falls under the General Hospital medical specialty and is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PXC
- Device Class
- FDA class 1
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.