(141 days)
The Impertech Surgical Face Mask are intended to be worn to protect 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 fluid. This is a single use, disposable device, provided non-sterile.
The Impertech Surgical Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the user's mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of melt blown fiber. The outer facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided non-sterile.
The provided text describes the acceptance criteria and the study conducted for the Impertech Surgical Face Mask to demonstrate its substantial equivalence to a predicate device. This is a 510(k) submission for a medical device (a surgical mask), not an AI/ML-enabled device. Therefore, many of the requested details, such as human reader studies, AI training data, and ground truth establishment for AI models, are not applicable to this document as it does not concern an AI system.
The study proves the device meets the acceptance criteria through non-clinical performance testing based on recognized standards for surgical masks.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The device is claiming to be an ASTM F2100 Level 3 Surgical Face Mask. The acceptance criteria are defined by the ASTM F2100 standard for Level 3, and the reported performance indicates that the Impertech Surgical Face Mask passes these criteria.
| Performance Testing Characteristic (ASTM F2100 Level 3 Requirement) | Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥98% | Pass | Yes |
| Differential Pressure (Airflow Resistance) |
§ 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.