(226 days)
The disposable surgical face masks 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.
The 3-ply surgical mask is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.
The provided text describes the acceptance criteria and performance study for a Surgical Mask - Level 3 & Procedure Mask - Level 3. This is a medical device (PPE), not an AI/software device, so the requested information regarding AI-specific studies (experts establishing ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable to this submission.
Here is the information directly relevant to the acceptance criteria and study for this physical device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Device Name: Surgical Mask - Level 3 & Procedure Mask - Level 3 (K202607)
| Item | Acceptance Criteria | Reported Device Performance (Subject Device) | Predicate Device Performance | Result |
|---|---|---|---|---|
| Level 3 Fluid Resistance (ASTM F1862) | 29 Out of 32 pass at 160 mmHg | 32 Out of 32 pass at 160 mmHg | 32 Out of 32 pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.67-99.80% | ≥99% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 99.6 - 99.9% | ≥99% | Pass |
| Differential Pressure (ASTM F2100) |
§ 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.