(134 days)
The Disposable Surgical Face Masks are 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 a single use, disposable device(s), provided non-sterile.
The proposed device(s) are White color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has 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 spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) premarket notification for a Surgical Face Mask. It details the device's technical characteristics, intended use, and comparison to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the standards for a Level 2 surgical face mask, primarily following ASTM F2100-11.
| Acceptance Criteria (ASTM F2100-11 Level 2 Standard) | Proposed Device Performance | Predicate Device Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862 at 120 mmHg) | 32 out of 32 pass | 32 out of 32 pass |
| Particulate Filtration Efficiency (ASTM F2299) | 99.88% pass | 98.46% pass |
| Bacterial Filtration Efficiency (ASTM F2101) | 99.6% pass | 98.7% pass |
| Differential Pressure (Delta P) (MIL-M-36954C) | 3.0 mmH2O/cm² pass | 4.2 mmH2O/cm² pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1 |
| Biocompatibility - Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility - Irritation | Non-irritating | Non-irritating |
| Biocompatibility - Sensitization | Non-sensitizing | Non-sensitizing |
2. Sample Size and Data Provenance for Test Set
- Fluid Resistance (ASTM F1862): 32 samples were tested. The country of origin for the data is not explicitly stated but implied to be from the manufacturer's testing (Xiantao Zhibo Non-woven Products Co., Ltd in China). The data is from non-clinical performance testing.
- For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), specific sample sizes are not provided in the summary, but the results indicate tests were conducted and met the criteria. The data provenance is non-clinical performance testing, likely conducted by or for the manufacturer.
3. Number of Experts and Qualifications for Ground Truth
This document describes technical performance testing of a physical device (surgical face mask), not an AI/software device that requires expert review for ground truth. Therefore, this section is not applicable. The "ground truth" here is established by standardized laboratory testing methods and measured physical properties.
4. Adjudication Method for Test Set
Not applicable, as this is laboratory testing of a physical product against defined standards, not an expert-driven assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a premarket notification for a physical medical device (surgical face mask), not an AI/software device that would typically undergo MRMC studies to assess human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable, as this is a physical medical device.
7. Type of Ground Truth Used
The ground truth is established through standardized laboratory testing protocols and measurements according to recognized consensus standards such as ASTM F2100-11, ASTM F1862, ASTM F2101, MIL-M-36954C, 16 CFR 1610, and ISO 10993 for biocompatibility. These standards define the methods and acceptance criteria for measuring specific physical and biological properties of the face mask.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device.
§ 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.