Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask

K202595 · Premier Guard USA, LLC · FXX · Jan 21, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202595
• Device Name: Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask
• Applicant: Premier Guard USA, LLC
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jan 21, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 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 non-sterile.

Device Story

Flat-pleated surgical mask; 3-layer construction; spunbond polypropylene inner/outer layers; meltblown fiber filter layer; elastic ear loops; polyethylene laminated soft annealed carbon steel wire nose piece. Single-use, disposable, non-sterile. Used in clinical settings for infection control; worn by healthcare personnel and patients. Provides physical barrier against microorganisms, body fluids, and particulates. Fluid resistance tested at 160 mmHg (ASTM F1862).

Clinical Evidence

No clinical data. Bench testing only. Performance testing included fluid resistance (ASTM F1862, 160 mmHg), particulate filtration efficiency (ASTM F2299, ≥98%), bacterial filtration efficiency (ASTM F2101, ≥98%), differential pressure (EN 14683, <6mmH2O/cm²), and flammability (16 CFR 1610, Class 1). Biocompatibility testing per ISO 10993-1:2018 included cytotoxicity (ISO 10993-5, Grade 0), sensitization (ISO 10993-10, no reactions), and irritation (ISO 10993-10, score 0).

Technological Characteristics

3-layer nonwoven polypropylene (spunbond outer/inner, meltblown filter). Nose piece: polyethylene laminated soft annealed carbon steel wire. Ear loops: nylon and spandex. Dimensions: 175mm x 95mm. ASTM F2100 Level 3. Non-sterile, single-use, disposable. No electronic components or software.

Indications for Use

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

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

• Wuhan Dymex Healthcare Co. Ltd. Surgical Face Mask (K182515)

Submission Summary (Full Text)

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January 21, 2021

Premier Guard USA LLC % Valerie Followell President-Owner Followell Compliance Consultants LLC 8049 Tripp Ave Skokie, Illinois 60076

Re: K202595

Trade/Device Name: Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 19, 2020 Received: December 21, 2020

Dear Valerie Followell:

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 (OS) 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 medical devices and radiation-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 CAPT Elizabeth Claverie, M.S. 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

510(k) Number (if known) K202595

Device Name

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask

Indications for Use (Describe)

The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 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 non-sterile.

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

| | For Activities Under EPA NPDES General Permit |
|--|-----------------------------------------------------|
| | For Other Activities Under EPA NPDES General Permit |

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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# K202595 510(k) SUMMARY

## Submission Correspondent

Contact Person: Valerie Followell Followell Compliance Consultants LLC 8049 Tripp Ave. Skokie, IL 60076 Phone: [phone] Email: [e-mail]

Premier Guard USA LLC 460 Briarwood Drive, Suite 400 Jackson, MS 39206 Phone: [phone] Email: [e-mail]

# Date Prepared

January 7, 2021

## Device Information

Trade Name: Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask Common Name: Surgical Mask Classification Name: Surgical Mask Product Code: FXX Classification Panel: General Hospital Regulatory Class: Class II Regulation Number: 21 CFR 878.4040

## Predicate Device Information

Wuhan Dymex Healthcare Co. Ltd. Surgical Face Mask K182515

## Device Description

The device description for the Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask is in accordance with the FDA Guidance Document, Surgical Masks – Premarket Notification [510K]] Submissions issued on March 5, 2004. The Premier Guard Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven

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Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask 510(k) Submission

polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided nonsterile.

The proposed device is not made from natural rubber latex.

#### Indications for Use

The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 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 fluid. This is a single use, disposable device, provided non-sterile

#### Summary of Technological Characteristics

| Device Characteristic | Proposed Device | Predicate Device | Comparison<br>Analysis |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Premier Guard USA 3 Layer Ear<br>Loop ASTM Level 3 Surgical<br>Face Mask | Wuhan Dymex Healthcare Co.<br>Ltd. Surgical Face Mask | Different |
| 510(k) Reference | K202595 | K182515 | Different |
| Product Owner | Premier Guard USA LLC | Wuhan Dymex Healthcare Co.,<br>Ltd. | Different |
| Product Code | FXX | FXX | Same |
| Indications for Use | The Premier Guard USA 3<br>Layer Ear Loop ASTM Level 3<br>Surgical Face Masks are<br>intended to be worn to<br>protect both patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material. These face masks<br>are intended for use in<br>infection control practices to<br>reduce the potential exposure<br>to blood and body fluids. This<br>is a single use, disposable<br>device(s) provided non-sterile. | The Disposable Surgical Face<br>Masks are intended to be<br>worn to protect both patient<br>and healthcare personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material. These face masks<br>are intended for use in<br>infection control practices to<br>reduce the potential exposure<br>to blood and body fluids. This<br>is a single use, disposable<br>device(s) provided non-sterile. | Same |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Mask Style | Flat Pleated, Ear Loops, 3<br>Layers | Flat Pleated, Ear Loops, 3<br>Layers | Same |
| Mask Color | Blue | Yellow | Different |

#### TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

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| Materials | | | |
|-------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|-----------|
| Nose Piece (material) | Polyethylene laminated soft annealed carbon steel wire | Malleable aluminum wire | Different |
| Ear Loops (material) | Nylon and Spandex | Spandex | Similar |
| Outer Facing Layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle Layer | Melt blown fiber | Melt blown polypropylene filter | Similar |
| Inner Facing Layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Dimensions - Width | 175mm | 17.5cm±1cm | Same |
| Dimensions - Length | 95mm | 9.5cm±1cm | Same |
| ASTM F2100 Level | Level 3 | Level 2 | Different |
| Biocompatibility | | | |
| Cytotoxicity | Under the conditions of the study, the device is non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic | Same |
| Sensitization | Under the conditions of the study, the device is non-sensitizing | Under the conditions of the study, the device is non-sensitizing | Same |
| Irritation | Under the conditions of the study, the device is non-irritating | Under the conditions of the study, the device is non-irritating | Same |
| Prescription vs. OTC | OTC | OTC | Same |
| Sterile vs. Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Disposable vs. Non-Disposable | Disposable | Disposable | Same |
| Single Use vs. Reusable | Single Use | Single Use | Same |

## Discussion of Similarities and Differences

The differences in material composition and the colorant do not raise new questions of safety or effectiveness as biocompatibility testing was performed on the final finished device and the results demonstrate that the subject device is non-cytotoxic, nonsensitizing and non-irritating.

When tested for fluid resistance per ASTM F1862 at 160 mmHg the Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask met the requirements for a level 3 face mask. The predicate device was tested at 120 mmHg, therefore, meeting the requirements for a level 2 face mask. The Premier Guard USA 3 Layer Ear Loop ASTM

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Level 3 Surgical Face Mask provided a higher level of fluid resistance as compared to the predicate device and when tested per ASTM F1862.

#### Summary of Testing and Supporting Information

Testing was conducted to demonstrate substantial equivalence of the Premier Guard USA 3 Laver Ear Loop ASTM Level 3 Surgical Face Mask to the predicate, Wuhan Dymex Healthcare Co. Ltd. Surgical Face Mask K182515.

Premier Guard USA followed the "Guidance for Industry and FDA Staff Surgical Masks -Premarket Notification [510(k)] Submissions Document [Issued on: March 5, 2004 and a correction posted on July 14, 2004]".

A summary of testing is presented below with more information provided in the applicable sections.

#### Non-Clinical Performance Testing

The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask was tested in accordance with the tests recommended in the FDA guidance document, Guidance for Industry and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission issued March of 2004. Based upon the guidance document the following testing has been performed.

- Fluid Resistance per ASTM F1862
- Particulate Filtration Efficiency per ASTM F2299
- Bacterial Filtration Efficiency per ASTM F2101
- Differential Pressure (Delta P) per EN 14683
- Flammability per 16 CFR 1610

| Test | Subject Device | Acceptance Criteria | Result | |
|-----------------------------------------------|-------------------------------------------------|-----------------------------------------------|-------------|------|
| Fluid Resistance<br>Performance ASTM<br>F1862 | Pass at 160 mmHg | 29 out of 32 pass at 160<br>mmHg | Pass | |
| | Particulate Filtration<br>Efficiency ASTM F2299 | ≥98% | ≥98% | Pass |
| | | Bacterial Filtration<br>Efficiency ASTM F2101 | ≥98% | ≥98% |
| Differential Pressure<br>(Delta P) EN 14683 | <6mmH2O/cm² | | <6mmH2O/cm² | Pass |
| | Flammability<br>16 CFR 1610 | Class 1 | Class 1 | Pass |

#### TABLE 2: PERFORMANCE TESTING

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# Performance Testing (Animal)

The biocompatibility evaluation for the Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask was conducted in accordance with ANSI/AAMI/ISO 10993-1:2018 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask is classified as a surface contacting device. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2018 Annex A.

| Test | Subject Device | Result |
|-------------------------------|----------------------------------------------------------------|--------|
| Cytotoxicity<br>ISO 10993-5 | Grade 0 | Pass |
| Sensitization<br>ISO 10993-10 | No sensitization reactions<br>were observed in test<br>animals | Pass |
| Irritation<br>ISO 10993-10 | Primary Irritation score=0<br>(Negligible) | Pass |

## TABLE 3: BIOCOMPATIBILITY TESTING

## Clinical Testing

This section does not apply. No clinical testing was performed.

## Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device, K182515 Wuhan Dymex Healthcare Co., Ltd. Surgical Face Masks.