(128 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.
Disposable Surgical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains tie strings (spun-bond polypropylene) or ear loops (Spandex elastic cord) to secure the mask over the users' mouth and face and includes a malleable nose piece (iron wire with plastic covering) to provide a firm fit over the nose.
This document is a 510(k) summary for a Disposable Surgical Face Mask. To provide a comprehensive answer regarding acceptance criteria and study proving device meets them, I will focus on the non-clinical performance tests which are detailed for this device. This document does not describe a clinical study or an AI/human-in-the-loop system.
Here's a breakdown based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by various ASTM standards (F2100, F1862, F2299, F2101) and others (MIL-M-36954C, 16 CFR Part 1610, ISO 10993 series). The device performance is compared to these standards across different performance levels (Level 1, Level 2, Level 3).
| Acceptance Criterion (Standard & Requirement) | Subject Device Performance (Disposable Surgical Face Mask K202491) | Predicate Device Performance (Surgical Face Mask K160269) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | |||
| Pass at 80 mmHg (Level 1, 2) | Pass at 80 mmHg | Pass at 80 mmHg | Same |
| Pass at 120 mmHg (Level 2) | Pass at 120 mmHg | Pass at 120 mmHg | Same |
| Pass at 160 mmHg (Level 3) | Pass at 160 mmHg | Pass at 160 mmHg | Same |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | |||
| Level 1 | Pass at >99.8% | Pass at 99.6% | Same / Better |
| Level 2 | Pass at 99.6% | Pass at 99.7% | Same |
| Level 3 | Pass at 99.6% | Pass at 99.7% | Same |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | |||
| Level 1 | Pass at ≥99.8% | Pass at >98% | Same / Better |
| Level 2 | Pass at >98% | Pass at >98% | Same |
| Level 3 | Pass at >99% | Pass at >99% | Same |
| Differential Pressure (Delta P) (MIL-M-36954C) | |||
| Level 1 | Pass at |
§ 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.