Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- 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
- ERYDrape, Surgical, Ent2Product Code
- EYXDrape, Pure Latex Sheet, With Self-Retaining Finger Cot2Product Code
- EYYDrape, Urological, Disposable2Product Code
- FXOSuit, Surgical1Product Code
- FXPCover, Shoe, Operating-Room1Product Code
- FXXMask, Surgical2Product Code
- FXYHood, Surgical2Product Code
- FXZHelmet, Surgical1Product Code
- FYAGown, Surgical2Product Code
- FYBGown, Patient2Product Code
- FYCGown, Isolation, Surgical2Product Code
- HMTDrape, Patient, Ophthalmic2Product Code
- HMWDrape, Microscope, Ophthalmic2Product Code
- KGOSurgeon'S Gloves1Product Code
- KGQCream, Gloving, Surgeon'S1Product Code
- KGTDrape, Adhesive, Aerosol1Product Code
- KKXDrape, Surgical2Product Code
- LGXTable, Examination, Medical, Powered1Product Code
- LYUAccessory, Surgical Apparel1Product Code
- MACDecontamination Kit1Product Code
- MMPCover, Barrier, Protective2Product Code
- MSHRespirator, Surgical2Product Code
- NZPSealant, Microbial2Product Code
- OEANon-Surgical Isolation Gown1Product Code
- OKFBody Fluid Disposal Kit2Product Code
- OKGBody Fluid Clean Up Kit2Product Code
- OKHBody Fluids Barrier Kit2Product Code
- OKIEmergency Response Safety Kit2Product Code
- ONTN95 Respirator With Antimicrobial/Antiviral Agent2Product Code
- OPAPowder-Free Non-Natural Rubber Latex Surgeon'S Gloves1Product Code
- OUKSurgical Mask With Antimicrobial/Antiviral Agent2Product Code
- OVRKit, First Aid, Talking1Product Code
- OXZPediatric/Child Facemask2Product Code
- PIRMercy Tape 2d And 3d Models1Product Code
- PLYAntimicrobial Drapes2Product Code
- PQMSurgical Smoke Precipitator2Product Code
- QBWSurgical Apparel With Material Claims2Product Code
- QMXLabel Or Tag, Non-Sterile1Product Code
- QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection2Product Code
- QSOMedical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs2Product Code
- 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
Body Fluid Clean Up Kit
- Page Type
- Product Code
- 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.
- Physical State
- 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.
- Technical Method
- 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.
- Target Area
- 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.
- Regulation Medical Specialty
- General and Plastic Surgery
- Review Panel
- General Hospital
- Submission Type
- Enforcement Discretion
- Device Classification
- Class 2
- Regulation Number
- 878.4040
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 878.4040 Surgical apparel
§ 878.4040 Surgical apparel.
(a) Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
(b) Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:
(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
[53 FR 23872, June 24, 1988, as amended at 65 FR 2317, Jan. 14, 2000; 83 FR 22848, May 17, 2018]