(226 days)
The following Liberty 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 masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These are single use, disposable device(s) provided non-sterile.
The LM Surgical Masks are white, single use, three-layer, pleated masks that come in 2 models: LM Surgical Mask Level 3 & LM Surgical Mask Level 2. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene. The masks are held in place over the users' mouth and nose by either two elastic ear loops, welded to the facemask. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose. The nose piece is made of polypropylene coated steel wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
Here's a breakdown of the acceptance criteria and study information for the "LM Surgical Mask Level 2" and "LM Surgical Mask Level 3," based on the provided FDA 510(k) summary:
This document describes a medical device clearance for surgical masks. These devices are typically evaluated through bench testing (non-clinical) to meet specific performance standards, rather than full clinical trials with patient outcomes. Therefore, most of the questions relating to clinical study design (experts, adjudication, MRMC, human-in-the-loop, training set details) are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Test | Acceptance Criteria (LM Surgical Mask Level 3 for PFE, BFE, Delta-P, and for Level 2 & 3 Flammability) | Reported Device Performance (LM Surgical Mask Level 3) | Acceptance Criteria (LM Surgical Mask Level 2) | Reported Device Performance (LM Surgical Mask Level 2) | Overall Result |
|---|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 160mmHg | 95 out of 96 samples passed (from 3 nonconsecutive lots) at 160mm Hg | 29 out of 32 pass at 160mmHg | 96 out of 96 samples passed (from 3 nonconsecutive lots) at 160mm Hg | Similar & Acceptable |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Average of 99.09% (96 out of 96 passed from 3 nonconsecutive lots) | ≥ 98% | Average of 98.42% (96 out of 96 passed from 3 nonconsecutive lots) | Similar & Acceptable |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Average of 99.60% (96 out of 96 passed from 3 nonconsecutive lots) | ≥ 98% | Average of 99.59% (96 out of 96 passed from 3 nonconsecutive lots) | Similar & Acceptable |
| Differential Pressure (Delta-P) (MIL-M-36954C) |
§ 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.