R&G Surgical Mask

K232112 · R&G Seguridad E Higiene Industrial S.A.C. · FXX · Apr 2, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K232112
• Device Name: R&G Surgical Mask
• Applicant: R&G Seguridad E Higiene Industrial S.A.C.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Apr 2, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended 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.

Device Story

Single-use, three-layer, flat-pleated surgical mask; worn over mouth and nose; secured by elastic ear loops; includes adjustable nosepiece. Protects patient and healthcare personnel from microorganisms, body fluids, and particulates; reduces exposure to blood/body fluids. Used in clinical/infection control settings. Non-sterile, disposable.

Clinical Evidence

No clinical data. Bench testing only: ASTM F2101 (BFE ≥98%), EN 14683 (breathability ≤6.0 mm H2O/cm²), ASTM F3050 (PFE ≥85%), ASTM F1862 (fluid resistance at 120 mmHg), 16 CFR 1610 (Class 1 flame spread), and ISO 10993 biocompatibility series (cytotoxicity, sensitization, irritation).

Technological Characteristics

Three-layer construction: inner/outer layers spunbond polypropylene; middle layer meltblown filter. Ear loops: 80% polypropylene/20% spandex. Nosepiece: plastic-coated aluminum wire. Dimensions: 17.5cm x 9.5cm. Non-sterile. Meets ASTM F2100-23 Level 2 performance standards.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material, and to reduce exposure to blood and body fluids in infection control practices.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Disposable medical face mask (K202745)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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<br>Callao Lima 07046 Peru |
| Contact | Mrs. Pola Guanilo |
| Telephone | [phone] |
| E-mail | [e-mail] |

#### 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.

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| | K232112 | K202745 | Comparison |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Trade<br>Name | R&G Surgical Mask | Disposable medical<br>face mask | Similar |
| Regulation | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Indications For Use | The R&G Surgical<br>Mask is intended to<br>be worn to protect<br>both the patient and<br>healthcare personnel<br>from transfer of<br>microorganisms,<br>body fluids and<br>particulate material.<br>The face mask is<br>intended for use in<br>infection control<br>practices to reduce<br>the potential<br>exposure to blood<br>and body fluids. This<br>is a single use,<br>disposable device(s),<br>provided non-sterile. | The Disposable<br>medical face mask is<br>intended to be worn<br>to protect both the<br>patient and<br>healthcare personnel<br>from transfer of<br>microorganisms,<br>body fluids and<br>particulate material.<br>The face mask is<br>intended for use in<br>infection control<br>practices to reduce<br>the potential<br>exposure to blood<br>and body fluids. This<br>is a single use,<br>disposable device(s),<br>provided non sterile. | Similar |
| OTC/Rx | OTC | OTC | Same |
| Composite | 3 pleated non-woven<br>polypropylene layers | Flat Pleated, 3 layers | Similar |
| Internal layer<br>material | White spunbond<br>polypropylene non-<br>woven fabric | Spunbond<br>polypropylene | Similar |
| Middle Layer<br>Material | Melt blown filter | Melt blown<br>polypropylene | Similar |
| External Layer<br>Material | White spunbond<br>polypropylene non-<br>woven fabric | Spunbond<br>polypropylene | Similar |
| Nose Piece | Plastic-coated<br>aluminum wire | Galvanized iron wire | Different |
| Ear Loop Material | 80% polypropylene /<br>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<br>Level 2 | ASTM F2100<br>Level 2 | Similar |
| Cytotoxicity | Under the conditions<br>of the study, not | Under the conditions<br>of the study, not | Same |
| | cytotoxic | cytotoxic | |
| Sensitization | Under the conditions<br>of the study, not a<br>sensitizer | Under the conditions<br>of the study, not a<br>sensitizer | Same |
| Irritation | Under the conditions<br>of the study, not an<br>irritant | Under the conditions<br>of the study, not an<br>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<br>adequate bacterial<br>filtration efficiency | Under the<br>conditions of the<br>study, at least 98%<br>efficiency | Pass |
| EN 14683:2019+AC<br>Annex C | To demonstrate<br>acceptable<br>breathability | Under the<br>conditions of the<br>study, at most 6.0<br>mm H2O/cm² | Pass |
| ASTM F3050 | To demonstrate<br>adequate particulate<br>filtration efficiency | Under the<br>conditions of the<br>study, at least 85%<br>efficiency | Pass |
| ASTM F1862 | To demonstrate<br>adequate resistance<br>to liquids | Under the<br>conditions of the<br>study, passing at<br>120 mmHg<br>conditions | Pass |
| 16 CFR 1610 | To evaluate flame<br>spread resistance | Class 1 under the<br>conditions of the<br>testing | Pass |
| ASTM F2100-23 | To evaluate mask<br>performance | Level 2 under the<br>conditions of the<br>evaluation | Pass |
| ISO 10993-5 | To evaluate the<br>cytotoxic potential<br>of the mask | Under the<br>conditions of the<br>study, non-cytotoxic | Pass |
| ISO 10993-10<br>Sensitization | To evaluate the<br>sensitization<br>potential of the<br>mask | Under the<br>conditions of the<br>study, not a<br>sensitizer | Pass |
| ISO 10993-10<br>Irritation | To evaluate the<br>irritation potential of<br>the mask | Under the<br>conditions of the<br>study, not an<br>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.