(239 days)
The Surgical Mask is 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(s), provided non-sterile.
The Surgical Mask is a single use, Flat Pleated mask with ear loops and nose piece. The Surgical Mask is consisting of three layers, the inner and outer layers are made of spunbonded polypropylene, and the middle layer is made of melt blown polypropylene filter. The Surgical Mask uses different colors to distinguish the inner and outer layers, the inner layer is white and the outer layer is blue. The ear loops are held in place over the users' mouth and nose by 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, which is made of polypropylene and metal wire. The Surgical Mask is sold non-sterile and is intended to be single use, disposable devices.
This document describes the premarket notification (510(k)) for a Surgical Mask (K201852) and its substantial equivalence to a predicate device (K182515). The information provided focuses on non-clinical performance testing to demonstrate this equivalence. Since this is a submission for a Surgical Mask, the "device" in the context of your request refers to the surgical mask itself, not an AI or software-based medical device.
Therefore, many of the questions you've asked, which are typically relevant for AI/ML-based medical devices, are not applicable to this submission. This document does not describe an AI/ML device that requires a test set, ground truth established by experts, MRMC studies, or training sets.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristics | Test Method | Acceptance Criteria | Test Result |
|---|---|---|---|
| Fluid Resistance Performance | ASTM F1862/F1862M-17 | 29 out of 32 passes at 120mmHg | 32 out of 32 passes at 120mmHg |
| Particulate Filtration Efficiency | ASTM F2299/F2299M-03 | ≥98% | 99.79% |
| Bacterial Filtration Efficiency | ASTM F2101-19 | ≥98% | 99.70% |
| Differential Pressure (ΔΡ) | 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.