(58 days)
A Surgical Mask is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate materials.
Not Found
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for an "Earloop Procedure Mask", which primarily confirms that the device is substantially equivalent to a legally marketed predicate device.
It details:
- The applicant, device name, regulation number, and classification.
- The FDA's review and determination of substantial equivalence.
- General controls and additional controls that may apply to the device.
- Contact information for specific advice from the FDA.
- The "Indications for Use" for the surgical mask, stating its purpose to protect patients and personnel from the transfer of microorganisms, body fluids, and particulate materials.
- A checkbox indicating "Over-The-Counter Use".
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes, data provenance, or ground truth establishment.
- Details about expert involvement, adjudication methods, or MRMC studies.
- Standalone algorithm performance or training set details.
Therefore, I cannot fulfill your request based on the provided text.
§ 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.