(169 days)
The Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop 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 Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical Masks 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 proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric.
The Disposable Medical Surgical Masks is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with Polyurethane fiber and Nylon.
The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PE and iron wire.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
The proposed device(s) are meet the Level 3 Barrier requirements per ASTM F2100-19.
This document is a 510(k) Premarket Notification for a medical device (Disposable Medical Surgical Masks). It is a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to the predicate device based on non-clinical performance and specifications.
Therefore, many of the typical acceptance criteria and study details relevant to AI/ML-based medical devices (like MRMC studies, expert adjudication, separate training/test sets for AI, human-in-the-loop performance, etc.) are not applicable to this document, as it describes a physical medical device (surgical masks) and its performance based on standardized material testing.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on meeting established industry standards for surgical masks, primarily ASTM F2100-19 for medical face mask materials, and other related standards (ISO 10993 for biocompatibility, ASTM F1862 for fluid resistance, etc.). The reported device performance is presented in comparison to these standards and a predicate device.
Table of Acceptance Criteria and Reported Device Performance (Summary from Section 6 and 7):
| Test Item / Performance Characteristic | Acceptance Criteria (from ASTM F2100 Level 3 Requirements or relevant standard) | Proposed Device Reported Performance | Status (Meets/Exceeds/N/A) |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | 160 mmHg | 160 mmHg | Meets |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 98.02 - 98.80% | Meets/Exceeds |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | ≥ 98% | 99.6 - 99.7% | Meets/Exceeds |
| Differential Pressure (MIL-M-36945C) |
§ 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.