Body Fluids Barrier Kit
The Body Fluids Barrier Kit (product code OKH) is a convenience kit designed to provide protective barriers against body fluid exposure, classified under 21 CFR 878.4040 in the General, Plastic Surgery specialty (SU). As a Class 2 device, it would ordinarily require 510(k) clearance, but the FDA's May 20, 1997 Convenience Kits Interim Regulatory Guidance places this kit type under enforcement discretion, exempting it from the premarket notification requirement when all guidance criteria are satisfied. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OKH
- Device Class
- FDA class 2
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- 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 www.fda.gov/cdrh/ode/convkit.html. 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 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.