(263 days)
The R&G Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is 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 R&G surgical mask is a single-use, three-layer, flat-pleated surgical mask with ear loops and nosepiece. The mask is made of three layers, the inner layer is made of white polypropylene nonwoven fabric, the outer layer is made of white polypropylene nonwoven fabrics, and the middle layer is made of meltblown fabrics. The mask is held in place over the wearer's mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are made of 80% polypropylene + 20% spandex. The nose piece on the mask is to allow the user to adjust the mask around their nose and is made of 75% plastic + 25% wire. The R&G surgical mask will be supplied in white. The mask is sold unsterilized and is intended to be a single-use disposable device.
This document is a 510(k) summary for the R&G Surgical Mask (K232112). This submission focuses on comparing the R&G Surgical Mask to a predicate device (K202745, Disposable medical face mask) to demonstrate substantial equivalence, rather than providing a detailed study of the R&G Surgical Mask's performance in isolation. Therefore, much of the requested information about device performance studies and ground truth establishment is not explicitly detailed in this document.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting Level 2 requirements of ASTM F2100-23, along with other specified standards.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM F2101-2023 (Bacterial Filtration Efficiency) | At least 98% efficiency | Pass |
| EN 14683:2019+AC Annex C (Breathability) | At most 6.0 mm H2O/cm² | Pass |
| ASTM F3050 (Particulate Filtration Efficiency) | At least 85% efficiency | Pass |
| ASTM F1862 (Resistance to Liquids) | Passing at 120 mmHg conditions | Pass |
| 16 CFR 1610 (Flame Spread Resistance) | Class 1 under the conditions of the testing | Pass |
| ASTM F2100-23 (Mask Performance) | Level 2 under the conditions of the evaluation | Pass |
| ISO 10993-5 (Cytotoxicity) | Non-cytotoxic | Pass |
| ISO 10993-10 (Sensitization) | Not a sensitizer | Pass |
| ISO 10993-10 (Irritation) | Not an irritant | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each of the non-clinical tests. The tests are general performance and biocompatibility tests on the device material, not a clinical performance study with patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical sense; the data would originate from specialized testing laboratories conducting the specified ASTM, EN, and ISO tests on samples of the R&G Surgical Mask.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for these tests is established by standardized testing protocols and measurements as per the listed ASTM, EN, and ISO standards, not by expert consensus on clinical cases. The tests measure objective physical and biological properties.
4. Adjudication method for the test set
Not applicable. As described above, the tests are objective measurements against established standard criteria, not interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for a surgical mask, not an AI-assisted diagnostic or therapeutic device. There is no MRMC study or AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a submission for a surgical mask, not an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical testing comprises the defined pass/fail criteria established by the respective international and national standards (ASTM, EN, ISO, 16 CFR). These standards outline specific methods and thresholds for evaluating bacterial filtration, breathability, fluid resistance, flammability, cytotoxicity, sensitization, and irritation.
8. The sample size for the training set
Not applicable. There is no training set in the context of this surgical mask submission. The device is a physical product, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 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.