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.

Device Description

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.

AI/ML Overview

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.

Summary

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April 2, 2024

R&G Seguridad e Higiene Industrial S.A.C. % Juan Tezak Consultant Compliance 4 Devices 118 W Prive Cr. Delray Beach, Florida 33445

Re: K232112

Trade/Device Name: R&G Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 6, 2024 Received: March 6, 2024

Dear Juan Tezak:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K232112

Device Name

R&G Surgical Mask

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K232112

Prepared April 1, 2024

l) Applicant

Submitter	R&G Seguridad e Higiene Industrial S.A.C.
Address	Mz. V Lt. 11-15 Urb. Los Carrizales VentanillaCallao Lima 07046 Peru
Contact	Mrs. Pola Guanilo
Telephone	+51 934 309045
E-mail	pguanilo@rygsa.com

II) Device

Trade Name	R&G Surgical Mask
Common Name	Surgical apparel
Classification Name	Mask, Surgical
Regulation Number	21 CFR 878.4040
Product Code	FXX

III) Predicate Device

510(k) Number	K202745
Applicant	Ningbo Jingeao Electronics Inc.
Trade Name	Disposable medical face mask
Classification Name	Mask, Surgical
Regulation Number	878.4040

IV) Indication For Use

V) Device Description

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	K232112	K202745	Comparison
Product TradeName	R&G Surgical Mask	Disposable medicalface mask	Similar
Regulation	21 CFR 878.4040	21 CFR 878.4040	Same
Indications For Use	The R&G SurgicalMask is intended tobe worn to protectboth the patient andhealthcare personnelfrom transfer ofmicroorganisms,body fluids andparticulate material.The face mask isintended for use ininfection controlpractices to reducethe potentialexposure to bloodand body fluids. Thisis a single use,disposable device(s),provided non-sterile.	The Disposablemedical face mask isintended to be wornto protect both thepatient andhealthcare personnelfrom transfer ofmicroorganisms,body fluids andparticulate material.The face mask isintended for use ininfection controlpractices to reducethe potentialexposure to bloodand body fluids. Thisis a single use,disposable device(s),provided non sterile.	Similar
OTC/Rx	OTC	OTC	Same
Composite	3 pleated non-wovenpolypropylene layers	Flat Pleated, 3 layers	Similar
Internal layermaterial	White spunbondpolypropylene non-woven fabric	Spunbondpolypropylene	Similar
Middle LayerMaterial	Melt blown filter	Melt blownpolypropylene	Similar
External LayerMaterial	White spunbondpolypropylene non-woven fabric	Spunbondpolypropylene	Similar
Nose Piece	Plastic-coatedaluminum wire	Galvanized iron wire	Different
Ear Loop Material	80% polypropylene /20% spandex	Polyester / spandex	Different
Color	White	Blue	Different
Mask Length	17.5cm ± 0.5cm	17.5cm ± 0.5cm	Same
Mask Width	9.5cm ± 0.5cm	9.5cm ± 0.5cm	Same
Sterility	Non-sterile	Non-sterile	Same
ASTM F2100	ASTM F2100-23Level 2	ASTM F2100Level 2	Similar
Cytotoxicity	Under the conditionsof the study, not	Under the conditionsof the study, not	Same
	cytotoxic	cytotoxic
Sensitization	Under the conditionsof the study, not asensitizer	Under the conditionsof the study, not asensitizer	Same
Irritation	Under the conditionsof the study, not anirritant	Under the conditionsof the study, not anirritant	Same

Comparison of Technological Characteristics VI)

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The differences in material and color on safety and performance do not prevent the subject device from achieving similar acceptable biocompatibility and compliance with ASTM F2100 Level 2 performance requirements.

VIII) Summary of Non-Clinical Testing

Test	Purpose	Criteria	Result
ASTM F2101-2023	To demonstrateadequate bacterialfiltration efficiency	Under theconditions of thestudy, at least 98%efficiency	Pass
EN 14683:2019+ACAnnex C	To demonstrateacceptablebreathability	Under theconditions of thestudy, at most 6.0mm H2O/cm²	Pass
ASTM F3050	To demonstrateadequate particulatefiltration efficiency	Under theconditions of thestudy, at least 85%efficiency	Pass
ASTM F1862	To demonstrateadequate resistanceto liquids	Under theconditions of thestudy, passing at120 mmHgconditions	Pass
16 CFR 1610	To evaluate flamespread resistance	Class 1 under theconditions of thetesting	Pass
ASTM F2100-23	To evaluate maskperformance	Level 2 under theconditions of theevaluation	Pass
ISO 10993-5	To evaluate thecytotoxic potentialof the mask	Under theconditions of thestudy, non-cytotoxic	Pass
ISO 10993-10Sensitization	To evaluate thesensitizationpotential of themask	Under theconditions of thestudy, not asensitizer	Pass
ISO 10993-10Irritation	To evaluate theirritation potential ofthe mask	Under theconditions of thestudy, not anirritant	Pass

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VIII) Summary of Clinical Testing

No clinical testing was performed in support of this submission.

IX) Conclusion

The conclusions drawn from the non-clinical testing demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K202745.

Regulation Number and Section

§ 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.