(188 days)
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, body fluids, and particulate materials.
Surgical Face Mask is a non-sterile, single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2 options for the Surgical Face Mask to be secured on user via earloops (model CM2006 and A88) or ties (model CM2008). Earloops are of Chinlon+Spandex Elastic Fiber (model CM2006) and polyester fibre (model A88) and not made with natural rubber latex; and ties are of spun-bond polypropylene and also not made with natural rubber latex. The nose piece is a single galvanize wire, coated by Polyethylene (model CM2006 and CM2008) and aluminum (model A88). All of the materials used in the construction of the surgical face mask are being used in currently marketed devices.
The provided text describes a 510(k) submission for a Surgical Face Mask and outlines the performance criteria and testing conducted to demonstrate substantial equivalence to a predicate device. This is a medical device submission, not an AI/ML product, so the questions regarding AI/ML-specific criteria (like effect size of AI assistance, AI-only performance, training set details) are not applicable.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance ASTM F1862-17 | To evaluate the effectiveness of the test article in protecting the user from possible exposure to body fluids. | No penetration pass at 160mmHg | Pass, no penetration pass at 160mmHg. |
| Particulate Filtration Efficiency ASTM F2299-17 | To evaluate the effectiveness of the test article in protecting the user from possible exposure to particulates. | ≥98% | Pass, CM2006 and CM2008: Average 99.88%; A88: Average 99.56% |
| Bacterial Filtration Efficiency ASTM F2101-19 | To evaluate the bacterial filtration efficiency (BFE) of mask. | ≥98% | Pass, CM2006 and CM2008: Average 99.88%; A88: Average 99.9% |
| Differential Pressure (Delta P) EN 14683:2019, Annex C and ASTM F2100-19 | To measure the differential pressure of mask which is related to breathability. |
§ 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.