Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.

Therapeutic

No.
This device is a surgical mask intended for infection control and protection from transfer of microorganisms, not for treating any medical condition or disease.

Diagnostic

No

This device is a surgical mask intended for protection and infection control, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, multi-layered surgical mask made of various fabrics and materials, with performance studies focused on physical properties like filtration, breathability, and flame resistance. There is no mention of software components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
Device Intended Use: The R&G Surgical Mask's intended use is to be worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
Device Description: The description details the physical construction of the mask and its components. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, breathability, fluid resistance, flammability) and its biocompatibility (cytotoxicity, sensitization, irritation). These are not studies related to diagnostic testing.

The R&G Surgical Mask is a Class II medical device (based on the predicate device K202745, which is a surgical mask) intended for infection control, not for diagnosing conditions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FXX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of Non-Clinical Testing:

ASTM F2101-2023: Purpose - To demonstrate adequate bacterial filtration efficiency; Criteria - Under the conditions of the study, at least 98% efficiency; Result - Pass
EN 14683:2019+AC Annex C: Purpose - To demonstrate acceptable breathability; Criteria - Under the conditions of the study, at most 6.0 mm H2O/cm²; Result - Pass
ASTM F3050: Purpose - To demonstrate adequate particulate filtration efficiency; Criteria - Under the conditions of the study, at least 85% efficiency; Result - Pass
ASTM F1862: Purpose - To demonstrate adequate resistance to liquids; Criteria - Under the conditions of the study, passing at 120 mmHg conditions; Result - Pass
16 CFR 1610: Purpose - To evaluate flame spread resistance; Criteria - Class 1 under the conditions of the testing; Result - Pass
ASTM F2100-23: Purpose - To evaluate mask performance; Criteria - Level 2 under the conditions of the evaluation; Result - Pass
ISO 10993-5: Purpose - To evaluate the cytotoxic potential of the mask; Criteria - Under the conditions of the study, non-cytotoxic; Result - Pass
ISO 10993-10 Sensitization: Purpose - To evaluate the sensitization potential of the mask; Criteria - Under the conditions of the study, not a sensitizer; Result - Pass
ISO 10993-10 Irritation: Purpose - To evaluate the irritation potential of the mask; Criteria - Under the conditions of the study, not an irritant; Result - Pass

Summary of Clinical Testing:
No clinical testing was performed in support of this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

bacterial filtration efficiency: at least 98% efficiency
breathability: at most 6.0 mm H2O/cm²
particulate filtration efficiency: at least 85% efficiency
resistance to liquids: passing at 120 mmHg conditions
flame spread resistance: Class 1

Predicate Device(s)

K202745

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

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)

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.

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 Ventanilla
Callao 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

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.

V) 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.

5

	K232112	K202745	Comparison
Product Trade
Name	R&G Surgical Mask	Disposable medical
face mask	Similar
Regulation	21 CFR 878.4040	21 CFR 878.4040	Same
Indications For Use	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 Disposable
medical face 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.	Similar
OTC/Rx	OTC	OTC	Same
Composite	3 pleated non-woven
polypropylene layers	Flat Pleated, 3 layers	Similar
Internal layer
material	White spunbond
polypropylene non-
woven fabric	Spunbond
polypropylene	Similar
Middle Layer
Material	Melt blown filter	Melt blown
polypropylene	Similar
External Layer
Material	White spunbond
polypropylene non-
woven fabric	Spunbond
polypropylene	Similar
Nose Piece	Plastic-coated
aluminum 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 F2100-23
Level 2	ASTM F2100
Level 2	Similar
Cytotoxicity	Under the conditions
of the study, not	Under the conditions
of the study, not	Same
	cytotoxic	cytotoxic
Sensitization	Under the conditions
of the study, not a
sensitizer	Under the conditions
of the study, not a
sensitizer	Same
Irritation	Under the conditions
of the study, not an
irritant	Under the conditions
of the study, not an
irritant	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 demonstrate
adequate bacterial
filtration efficiency	Under the
conditions of the
study, at least 98%
efficiency	Pass
EN 14683:2019+AC
Annex C	To demonstrate
acceptable
breathability	Under the
conditions of the
study, at most 6.0
mm H2O/cm²	Pass
ASTM F3050	To demonstrate
adequate particulate
filtration efficiency	Under the
conditions of the
study, at least 85%
efficiency	Pass
ASTM F1862	To demonstrate
adequate resistance
to liquids	Under the
conditions of the
study, passing at
120 mmHg
conditions	Pass
16 CFR 1610	To evaluate flame
spread resistance	Class 1 under the
conditions of the
testing	Pass
ASTM F2100-23	To evaluate mask
performance	Level 2 under the
conditions of the
evaluation	Pass
ISO 10993-5	To evaluate the
cytotoxic potential
of the mask	Under the
conditions of the
study, non-cytotoxic	Pass
ISO 10993-10
Sensitization	To evaluate the
sensitization
potential of the
mask	Under the
conditions of the
study, not a
sensitizer	Pass
ISO 10993-10
Irritation	To evaluate the
irritation potential of
the mask	Under the
conditions of the
study, not an
irritant	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.