(442 days)
The GOOD High Fluid-Resistant Surgical Mask and the KOEASY High Fluid-Resistant Surgical Mask 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The subject device includes six mask models. Each mask is composed of four-layers (outer non-woven layer, support layer, melt blown filter layer, and inner non-woven layer). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The masks are single use, disposable devices, provided non-sterile. These devices are not made from Natural Rubber Latex.
The provided text is a 510(k) summary for surgical masks, not an AI/ML-enabled medical device. Therefore, the information requested in your prompt regarding AI/ML performance metrics, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this document.
However, I can extract the acceptance criteria and non-clinical study results for these surgical masks, as presented in the document.
Acceptance Criteria and Reported Device Performance (Non-Clinical Testing for Surgical Masks)
The non-clinical tests were conducted to verify that the proposed device met design specifications and complied with relevant standards. The tests align with ASTM F2100 Level 3 barrier requirements.
| Performance Testing | Test Methodology | Acceptance Criteria: Level 3 Barrier | Reported Device Performance |
|---|---|---|---|
| Particulate Filtration Efficiency (PFE) | ASTM F2299-17 | ≥98% | Passed at ≥ 98% @ 0.1 micron |
| Fluid Resistance | ASTM F1862-17 | Pass at 160 mmHg | Passed at 160mm Hg |
| Bacterial Filtration Efficiency (BFE) | ASTM F2101-19 | ≥98% | Passed at ≥ 98% |
| Differential Pressure (Breathability) | EN 14683:2019 Annex C |
§ 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.