(252 days)
The Dukal Corporation Level 2 Surgical Mask with Ear Loops, Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
Face Masks intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
The provided text does not describe an AI/ML device but rather a surgical mask (Dukal Corporation Level 2 Surgical Mask with Ear Loops, Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons). Therefore, the information requested for AI/ML devices, such as sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable and cannot be extracted.
However, I can provide the acceptance criteria and the reported device performance for the surgical masks based on the provided text, as these are relevant to non-AI/ML medical devices.
1. A table of acceptance criteria and the reported device performance (for the Surgical Mask):
| Test Standards | ASTM Level 2 Requirements (Acceptance Criteria) | Subject Device (K201421) Reported Performance |
|---|---|---|
| ASTM F2101- Bacterial Filtration Efficiency (BFE) | ≥98% | >99% |
| ASTM F2299- Particulate Filtration Efficiency (PFE) | ≥98% | >99% |
| Mil-M-36954C, EN14683 - Differential Pressure (Breathability) |
§ 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.