Surgical Mask

K212451 · Remade USA, LLC · FXX · Sep 10, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K212451
• Device Name: Surgical Mask
• Applicant: Remade USA, LLC
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Sep 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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 is a single use, disposable device provided nonsterile.

Device Story

Disposable surgical face mask; 3-layer flat-pleated design; ear loops; nose piece. Outer/inner layers: 25gsm spunbond polypropylene; middle layer: 25gsm melt blown polypropylene filter. Used in clinical settings for infection control; worn by healthcare personnel and patients to reduce exposure to blood, body fluids, and particulates. Passive device; no electronic or software components. Provides physical barrier protection.

Clinical Evidence

No clinical data. Bench testing only. Device demonstrated compliance with ASTM F2100-19 (Level 3), ASTM F1862 (synthetic blood penetration), ASTM F2299 (particulate filtration efficiency ≥98%), ASTM F2101 (bacterial filtration efficiency ≥98%), EN 14683 (differential pressure <6.0 mmH2O/cm²), and 16 CFR 1610 (Class 1 flammability). Biocompatibility testing per ISO 10993-1, -5, and -10 confirmed non-cytotoxic, non-sensitizing, and non-irritating properties.

Technological Characteristics

3-layer flat-pleated mask. Materials: Spunbond polypropylene (outer/inner), melt blown polypropylene (filter). Nose piece: Galvanized iron wire coated with polypropylene. Ear loops: 80% nylon/20% spandex. Dimensions: 17.5cm x 9.5cm. Non-sterile, single-use. Passive device; no energy source, connectivity, or software.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material in infection control practices. Single-use, non-sterile, disposable device.

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

• Deme MASK Surgical Face Mask (K201479)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right is the FDA logo, with the acronym "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 10, 2021

ReMade USA LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K212451

Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 4, 2021 Received: August 5, 2021

# Dear Prithul Bom:

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 (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 located 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).

Sincerely.

For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212451

Device Name Surgical Mask

Indications for Use (Describe)

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 is a single use, disposable device provided nonsterile.

| Type of Use (Select one or both, as applicable) | <input type="checkbox"/> Renovation that is Part of CER 331 Subpart D <input checked="" type="checkbox"/> Construction that is CER 331 Subpart O |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|

__ 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 K212451

This summary of 510(k) is submitted in accordance with the requirements of 21 CFR \$807.92:

#### SUBMITTER .

ReMade USA LLC 2915 E Washington Blvd Los Angeles, CA 90023 USA Tel: [phone] Fax: N/A

Contact Person: David Durst Date Prepared: May 21, 2021

### DEVICE II.

| Name of Device: | Surgical Mask |
|------------------------------|------------------|
| Classification Name: | Surgical Mask |
| Regulation: | 21 CFR §878.4040 |
| Regulatory Class: | Class II |
| Product Classification Code: | FXX |

### . PREDICATE DEVICE

Predicate Manufacturer: Predicate Trade Name: Predicate 510(k):

DemeTECH Corporation Deme MASK Surgical Face Mask K201479

No reference devices were used in this submission.

### DEVICE DESCRIPTION IV.

The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with a nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.

### V. INDICATIONS FOR USE

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 is a single use, disposable device provided nonsterile.

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## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE

The following characteristics were compared between the subject device and the predicate device:

| Device | Proposed Device | Predicate Device | Result |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer | ReMade USA LLC | DemeTECH Corporation | - |
| 510K Number | K212451 | K201479 | - |
| Product<br>CommonName | SURGICAL MASK | DemeMASK Surgical Mask | Same |
| Product Code | FXX | FXX | Same |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same |
| Indications for<br>Use | The disposable surgical face<br>masks are intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms, body<br>fluids and particulate material.<br>These face masks are intended<br>for use in infection control<br>practices to reduce the potential<br>exposure to blood and body<br>fluids. This is a single use,<br>disposable device provided non-<br>sterile. | The disposable surgical face<br>masks are intended to be worn<br>to protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms, body<br>fluids and particulate material.<br>These face masks are intended<br>for use in infection control<br>practices to reduce the potential<br>exposure to blood and body<br>fluids. This is a single use,<br>disposable device provided non-<br>sterile. | Same |
| Model | 3 Ply, Ear Loops, Flat-Pleated<br>Style | 3 Ply, Ear Loops/Tie-on, Flat-<br>PleatedStyle | Similar |
| Materials | | | |
| Outer<br>Facing<br>Layer | Spunbond Polypropylene 25gsm | Spunbond Polypropylene | Same |
| Middle Layer | Melt Blown Polypropylene<br>Filter 25gsm | Melt Blown PolypropyleneFilter | Same |
| Inner Facing<br>Layer | Spunbond Polypropylene 25gsm | Spunbond Polypropylene | Same |
| Nose Piece | Single Galvanized Iron Wire,<br>coated with Polypropylene<br>$3.0mm\pm1.0mm$ Length/1<br>$\pm0.1mm$ Thick/ $0.5\pm0.01mm$<br>Diameter | Galvanized wire coated with PE<br>(Dimensions Unknown) | Similar |
| Ear Loops | 80% Nylon; 20% Spandex<br>Length: $4.0mm\pm0.15$ , Thickness:<br>$1.0mm\pm0.15mm$ | Polyester spandex blend | Similar |
| Color | Blue | White | Different |
| Dimension<br>(Width) | $9.5 cm \pm 1cm$ | $9.5cm \pm 1cm$ | Same |
| Dimension<br>(Length) | $17.5 cm \pm 1cm$ | $17.5cm \pm 1cm$ | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100<br>Level | Level 3 – ASTM F2100-19 | Level 3 – ASTM F2100-19 | Same |

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# VII. SUMMARY of NON-CLINICAL PERFORMANCE TESTING

The subject device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004. A summary of the benchtop performance testing results is provided below in Table 2.

| Item | Purpose | Acceptance Criteria | Subject Device - ReMade<br>Surgical Mask |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Level 3<br>Resistance to<br>Penetration by<br>Synthetic Blood<br>STM F1862 | The purpose of<br>this testing is to<br>demonstrate<br>the Resistance<br>to Penetration<br>by Synthetic<br>Blood ASTM<br>F1862 of the<br>subject device. | 29 Out of 32<br>pass at 160 mmHg | Three non-sequential lots<br>of 32 (total of 96, AQL<br>4.0) passed at 160mmHg<br>Lot 1: 32/32 passed.<br>Lot 2: 32/32 passed.<br>Lot 3: 32/32 passed |

Table 2 – Benchtop Performance Testing

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| Particulate<br>Filtration<br>Efficiency ASTM<br>F2299 | The purpose of<br>this testing is to<br>demonstrate the<br>Particulate<br>Filtration<br>Efficiency ASTM<br>F2299 of the<br>subject device. | ≥ 98% | Three non-sequential lots of 32<br>(total of 96, AQL 4.0) passed at<br>≥98%<br>Lot 1: 32/32 passed.<br>Lot 2: 32/32 passed.<br>Lot 3: 32/32 passed |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bacterial<br>Filtration<br>Efficiency ASTM<br>F2101 | The purpose of this<br>testing is to<br>demonstrate the<br>Bacterial Filtration<br>Efficiency ASTM<br>F2101 of the subject<br>device. | ≥ 98% | Three non-sequential lots of 32<br>(total of 96, AQL 4.0) passed at<br>≥98% - ASTM F2101<br>Lot 1: 32/32 passed.<br>Lot 2: 32/32 passed.<br>Lot 3:32/32 passed |
| Differential<br>Pressure EN<br>14683:2019 | The purpose<br>of this testing<br>is to<br>demonstrate<br>the<br>Differential<br>Pressure EN<br>14683:2019<br>of the subject<br>device. | < 6.0<br>mmH20/cm² | Three non-sequential lots of 32<br>(total of 96, AQL 4.0) passed at<br><6.0 H2O/cm2<br>Lot 1: 32/32 passed.<br>Lot 2: 32/32 passed.<br>Lot 3: 32/32 passed. |
| Class 1<br>Flammability 16<br>CFR 1610 | The purpose of this<br>testing is to<br>demonstrate the<br>Flammability 16<br>CFR 1610 of the<br>subject device. | Class 1:<br>< 3.5 second burn time | Three non-sequential lots of 32<br>(total of 96, AQL<br>4.0) passed Class 1 16<br>CFR 1610<br>Lot 1: 32/32 passed (DNI)<br>Lot 2: 32/32 passed (DNI)<br>Lot 3: 32/32 passed (DNI) |

# Sterilization & Shelf-life Testing

Not Applicable (This is a non-sterile device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.)

# Biocompatibility Testing

Biocompatibility testing was performed in accordance with ISO 10993-1:2018. Specifically, the following testing endpoints were evaluated.

| Biocompatibility Testing Endpoints | Acceptance Criteria | Result |
|------------------------------------|---------------------|--------|
| Cytotoxicity - ISO 10993-5 | Non-Cytotoxic | Pass |
| Skin Sensitization - ISO 10993-10 | Non- Sensitizing | Pass |
| Skin Irritation - ISO 10993-10 | Non-Irritating | Pass |

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# Table 4 - Summary of Non-Clinical Performance Testing

The following standards have been used to evaluate the ReMade USA Surgical Mask:

| ASTM F2100 | Standard Specification for Performance of Materials Used in Medical<br>Face Masks |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM F1862 | Standard Test Method for Resistance of Medical Face Masks to<br>Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume<br>at a Known Velocity) |
| ASTM F2299 | Standard Test Method for Determining the Initial Efficiency of Materials<br>Used in Medical Face Masks to Penetration by Particulates Using Latex<br>Spheres |
| ASTM F2101 | Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE)<br>of Medical Face Mask Materials, Using a Biological Aerosol of<br>Staphylococcus aureus |
| EN 14683:2019 | Standard Test Method for Differential Pressure |
| 16 CFR Part 1610 | Standard for Flammability |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing<br>within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro<br>cytotoxicity of medical devices |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and<br>skin sensitization |

# Software Verification and Validation Testing

Not Applicable (Passive Device)

# Electrical safety and electromagnetic compatibility (EMC)

Not Applicable (Passive Device)

# Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

# Human Clinical Performance Testing

Clinical testing was not required to demonstrate the safety and effectiveness of the device.

# VIII. CONCLUSIONS

The conclusions drawn from the performance data demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device K201479, DemeMASK Surgical Face Mask manufactured by DemeTECH Corporation.