(55 days)
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided nonsterile.
The Surgical Face Masks are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of outer facing layer and inner facing layer. The colorant is blue polypropylene (PP) master batch.
The outer facing layer and inner facing layer of the mask are made of spun-bond polypropylene, the middle layer is made of melt blown polypropylene. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped aluminium.
The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.
The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Surgical Face Masks.
Please find below the acceptance criteria and study information based on the provided text.
Note: The provided document is a 510(k) Premarket Notification for a Surgical Face Mask. It details performance testing against established standards for physical properties and biocompatibility, not for a software-based AI/ML medical device. Therefore, many of the requested categories (e.g., sample size for test set with data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with humans, training set details) are not applicable to this type of device and the information is not present in the document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.
Acceptance Criteria and Reported Device Performance
1. Table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria for Level 1 Barrier | Result |
|---|---|---|---|
| Bacterial Filtration Efficiency (ASTM F2101) | Measure bacterial filtration efficiency | $\ge$ 95% | Passed |
| Differential Pressure (mmH₂O/cm²) (EN 14683:2019 Annex C) | Determine breathability of the mask |
§ 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.