Surgical Mask

K210908 · Sichuan Prius Biotechnology Co., Ltd. · FXX · Sep 26, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210908
• Device Name: Surgical Mask
• Applicant: Sichuan Prius Biotechnology Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Sep 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Indications for Use

The surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Device Story

Single-use, three-layer, flat-pleated surgical mask; inner/outer layers PP spunbonded non-woven fabric; middle layer melt-blown non-woven fabric; galvanized iron wire nose clip; ear straps (spandex/polyester or PP non-woven). Available in ear-loop, tie-on, and headband styles; various sizes; sterile and non-sterile versions. Used in operating rooms and clinical settings by healthcare personnel to provide physical barrier against fluids and particulates; reduces risk of cross-contamination between patient and provider.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM F1862 (synthetic blood penetration), ASTM F2299 (particulate filtration efficiency >98%), ASTM F2101 (bacterial filtration efficiency >99%), EN 14683 (differential pressure <6.0 mmH2O/cm²), and 16 CFR Part 1610 (flammability Class 1). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Three-layer flat-pleated mask; PP spunbonded non-woven (inner/outer), melt-blown non-woven (middle). Galvanized iron wire nose clip. Ear straps: spandex/polyester or PP non-woven. Dimensions: 17.5x9.5cm or 14.5x9.5cm. Sterile (EO) or non-sterile. Fluid resistance: 120 mmHg. Flammability: Class 1. Complies with ASTM F1862, F2299, F2101, and EN 14683.

Indications for Use

Indicated for operating room personnel and general healthcare workers to protect patients and workers from microorganisms, blood, body fluids, and particulates.

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

• Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) (K202843)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

September 26, 2021

Sichuan Prius Biotechnology Co., Ltd. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai, 200120 China

Re: K210908

Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 9, 2021 Received: August 17, 2021

Dear Diana Hong:

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, 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 Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K210908

Device Name

Surgical Mask (Model numbers identified in the attachment)

Indications for Use (Describe)

The surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

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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| Model | Size (cm) | Ear loop | Headband | Tie-on | Sterile | Non-sterile | Non-edging type | Edging type |
|-----------|-----------|----------|----------|--------|---------|-------------|-----------------|-------------|
| PRS-WK001 | 17.5×9.5 | √ | | | √ | | | √ |
| PRS-WK002 | 17.5×9.5 | √ | | | √ | | √ | |
| PRS-WK003 | 17.5×9.5 | | √ | | √ | | | √ |
| PRS-WK004 | 17.5×9.5 | | √ | | √ | | √ | |
| PRS-WK005 | 17.5×9.5 | | | √ | √ | | NA | |
| PRS-WK006 | 14.5×9.5 | √ | | | √ | | | √ |
| PRS-WK007 | 14.5×9.5 | √ | | | √ | | √ | |
| PRS-WK008 | 14.5×9.5 | | √ | | √ | | | √ |
| PRS-WK009 | 14.5×9.5 | | √ | | √ | | √ | |
| PRS-WK010 | 14.5×9.5 | | | √ | √ | | NA | |
| PRS-WK016 | 17.5×9.5 | √ | | | | √ | | √ |
| PRS-WK017 | 17.5×9.5 | √ | | | | √ | √ | |
| PRS-WK018 | 17.5×9.5 | | √ | | | √ | | √ |
| PRS-WK019 | 17.5×9.5 | | √ | | | √ | √ | |
| PRS-WK020 | 17.5×9.5 | | | √ | | √ | NA | |
| PRS-WK021 | 14.5×9.5 | √ | | | | √ | | √ |
| PRS-WK022 | 14.5×9.5 | √ | | | | √ | √ | |
| PRS-WK023 | 14.5×9.5 | | √ | | | √ | | √ |
| PRS-WK024 | 14.5×9.5 | | √ | | | √ | √ | |
| PRS-WK025 | 14.5×9.5 | | | √ | | √ | NA | |

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# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K210908

- 1. Date of Preparation: 09/14/2021
- 2. Sponsor Identification

## Sichuan Prius Biotechnology Co., Ltd.

No. 2, Prius Road, Luo Long Industrial Park Nanxi District, 644104 Yibin City, Sichuan Province, PEOPLE'S REPUBLIC OF CHINA.

Establishment Registration Number: Not registered yet.

Contact Person: Yan Liu Position: management representative Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone] Fax: [phone] Email: [e-mail]

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- Identification of Proposed Device 4.
Product Name: Surgical Mask Common Name: Surgical Masks

Regulatory Information Classification Number: 21 CFR 878.4040 Classification Name: Surgical apparel Product Code: FXX Regulatory Class: II Review Panel: General Hospital

- 5. Identification of Predicate Device
510(k) Number: K202843 Product Name: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) Sponsor Name: B.J.ZH.F. Panther Medical Equipment Co., Ltd. Whether subject to a design-related recall: No

#### 6. Device Description:

The proposed device, Surgical Mask, is a single use, three-layer, flat-pleated mask. The inner and outer layers of the mask are made of PP Spunbonded Non-woven Fabric, and the middle layer is made of Melt-blown Nonwoven Fabric. The proposed devices are available in three types, ear-loop, Tie-on and Headband. The ear straps of headband type and ear loop type are made of Spandex and Polyester, and the ear strap of tie-on type is made of PP Spunbonded Non-woven Fabric. The ear strap is held in place over the users' mouth and nose. The nose clip is made of Galvanized Iron Wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops, tie-on and headband masks are available in different sizes to provide more options for user, as shown in the following table. The proposed devices were available with and without edging and they can be provided in sterile and non-sterile two versions. The proposed devices are blue.

| Model | Sterile | Non-<br>sterile | Ear<br>loop | Tie-on | Headband | Size<br>(cm) | Non-edging<br>type | Edging<br>type | Color |
|-----------|---------|-----------------|-------------|--------|----------|--------------|--------------------|----------------|-------|
| | | | | | | | | | |
| PRS-WK002 | √ | | √ | | | 17.5×9.5 | √ | | Blue |
| PRS-WK003 | √ | | | | √ | 17.5×9.5 | | √ | Blue |
| PRS-WK004 | √ | | | | √ | 17.5×9.5 | √ | | Blue |
| PRS-WK005 | √ | | | √ | | 17.5×9.5 | NA | | Blue |

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| PRS-WK006 | √ | √ | 14.5×9.5 | √ | Blue |
|-----------|---|---|----------|----|------|
| PRS-WK007 | √ | | 14.5×9.5 | √ | Blue |
| PRS-WK008 | √ | | 14.5×9.5 | √ | Blue |
| PRS-WK009 | √ | | 14.5×9.5 | √ | Blue |
| PRS-WK010 | √ | | 14.5×9.5 | NA | Blue |
| PRS-WK016 | | √ | 17.5×9.5 | √ | Blue |
| PRS-WK017 | | √ | 17.5×9.5 | √ | Blue |
| PRS-WK018 | | √ | 17.5×9.5 | √ | Blue |
| PRS-WK019 | | √ | 17.5×9.5 | √ | Blue |
| PRS-WK020 | | √ | 17.5×9.5 | NA | Blue |
| PRS-WK021 | | √ | 14.5×9.5 | √ | Blue |
| PRS-WK022 | | √ | 14.5×9.5 | √ | Blue |
| PRS-WK023 | | √ | 14.5×9.5 | √ | Blue |
| PRS-WK024 | | √ | 14.5×9.5 | √ | Blue |
| PRS-WK025 | | √ | 14.5×9.5 | NA | Blue |

#### 7. Indications for Use:

The surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

- 8. Summary of Technological characteristics

| ITEM | Proposed Device | Predicate Device K202843 | Remark |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for Use | The surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. | The Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. | Same |
| Mask style | Flat-pleated, 3 layers | Flat-pleated, 3 layers | Same |
| Color | Blue | Blue | Same |
| Dimension | | | |
| | 17.5cm×9.5cm<br>14.5cm×9.5cm | 17.5cm×9.5cm<br>14.5cm×9cm | Same |
| Level | Level 2 | Level 2 | Same |
| Sterility | Sterile/Non-Sterile | Sterile/Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Fluid resistance | Sterile: Pass at 120mmHg<br>Non-sterile: Pass at 120mmHg | Pass at 120mmHg | Same |
| Particulate Filtration Efficiency | Sterile: Average 98.21%<br>Non-sterile: Average 98.20% | Average 98.98% | Different |
| Bacterial Filtration Efficiency | Sterile: Average 99.64%<br>Non-sterile: Average 99.60% | Average 98.92% | Different |
| Differential Pressure | Sterile: Average 3.02 mmH2O/cm²<br>Non-sterile: Average 2.87 mmH2O/cm² | Average 4.4 mmH2O/cm² | Different |
| Flammability | Class 1 | Class 1 | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Patient Contacting Material | | | |
| Outer layer of mask | PP Spunbonded Non-woven Fabric | Spun-bonded nonwoven polypropylene | |
| Middle layer of mask | Melt-blown Nonwoven Fabric | Melt-blown non-woven polypropylene | |
| Inner layer of mask | PP Spunbonded Non-woven Fabric | Spun-bonded nonwoven polypropylene | Different |
| Nose Clip | Galvanized Iron Wire | Medical polypropylene and Q235 | |
| Ear Strap | PP Spunbonded Non-woven Fabric; Spandex and Polyester | Spun-bonded nonwoven polypropylene; Spandex and nylon | |
| Biocompatibility | | | |
| Cytotoxicity | ISO 10993-5 and ISO 10993-10;<br>Under the conditions of the study, the | ISO 10993-5 and ISO 10993-10;<br>Under the conditions of the study, | |
| Sensitization | proposed device extract was determined to be non-cytotoxic, | the proposed device extract was determined to be non-cytotoxic, | same |
| Irritation | non-sensitizing, and non-irritating. | non-sensitizing, and non-irritating. | |
| Test Method | Purpose | Acceptance Criteria | Results |
| Cytotoxicity | The test was performed in accordance with ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity to evaluate the cytotoxicity of the test sample. | The viability should be $\geq$ 70% of the blank. And the 50% extract of the test sample should have at least the same or a higher viability than the 100% extract. | The viability of the tested samples included PRS-WK002 and PRS-WK017 was $\geq$ 70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract.<br><br>Under the conditions of the study, the proposed device was non-cytotoxic. |
| Sensitization | The test was performed in accordance with ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization to evaluate the sensitization of the test | Non-sensitizing | The tested samples included PRS-WK002 and PRS-WK017 showed no evidence of causing delayed dermal contact sensitization in the guinea pigs.<br><br>Under the conditions of the study, the proposed device was non-sensitizing. |

Table 1 Comparison of Surgical Mask

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Differences in technological characteristics do not raise different questions of safety and effectiveness.

#### 9. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications. The

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test results demonstrated that the proposed device complies with the following standards:

- > 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- > ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- > ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
- > ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- > EN 14683: 2019 Medical face masks- Requirements and test methods
- A ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- > ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
- > ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- > ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- > ISO 10993-7:2008 Biological Evaluation of Medical Device-Part 7: Ethylene Oxide Sterilization Residuals

### Table 2 Biocompatibility Testing

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| | sample. | | |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Irritation | The test was performed in<br>accordance with ISO<br>10993-10 Third Edition<br>2010-08-01 Biological<br>evaluation of medical<br>devices - Part 10: Tests for<br>irritation and skin<br>sensitization to evaluate the<br>irritation of the test sample. | Non-irritating | The irritation response category of<br>the test samples included<br>PRS-WK002 and PRS-WK017 was<br>classified as Negligible for polar<br>extract and Negligible for non-polar<br>extract.<br><br>Under the conditions of the study,<br>the proposed device was<br>non-irritating. |

| Table 3 Performance Testing | |
|-----------------------------|--|
|-----------------------------|--|

| Test Method | Purpose | Acceptance Criteria | Results |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Resistance to<br>Penetration by<br>Synthetic<br>blood | The test was performed in<br>accordance with ASTM<br>F1862/F1862M:<br>2017<br>Standard Test Method for<br>Resistance of Medical Face<br>Masks to Penetration by<br>Synthetic Blood (Horizontal<br>Projection of Fixed Volume<br>at a Known Velocity) to<br>evaluate the effectiveness of<br>the test sample from possible<br>exposure to blood and other<br>body fluids. | No penetration at 120<br>mmHg | Sterile Ear loop Non-edging<br>(PRS-WK002):<br>Lot 200401: Pass at 120mmHg<br>Lot 200407: Pass at 120mmHg<br>Lot 200413: Pass at 120mmHg<br>Non-sterile Ear loop Non-edging<br>(PRS-WK017):<br>Lot 200401: Pass at 120mmHg<br>Lot 200405: Pass at 120mmHg<br>Lot 200407: Pass at 120mmHg |
| Particulate<br>Filtration<br>Efficiency | The test was performed in<br>accordance with ASTM<br>F2299/F2299M-03<br>(2017)<br>Standard Test Method for<br>Determining the Initial<br>Efficiency of Material Used<br>in medical Face Masks to<br>Penetration by Particulates<br>using Latex Spheres to<br>determine the particle<br>filtration efficiency (PFE) of<br>the test article. | ≥98% | Sterile Ear loop Non-edging<br>(PRS-WK002):<br>Lot 200401: 98.19%<br>Lot 200407: 98.20%<br>Lot 200413: 98.24%<br>Non-sterile Ear loop Non-edging<br>(PRS-WK017):<br>Lot 200401: 98.22%<br>Lot 200405: 98.16%<br>Lot 200407: 98.22% |
| Bacterial | The test was performed in | ≥98% | Sterile: Average 99.64% |
| Filtration Efficiency | accordance with ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus to determine the bacterial filtration efficiency (BFE) of the test article. | | Non-sterile: Average 99.60%<br>Sterile Ear loop Non-edging (PRS-WK002):<br>Lot 210405: 99.74%<br>Lot 210407: 99.72%<br>Lot 210409: 99.70%<br><br>Non-sterile Ear loop Non-edging (PRS-WK017):<br>Lot 210405: 99.56%<br>Lot 210407: 99.54%<br>Lot 210409: 99.53% |
| Differential Pressure | The test was performed in accordance with EN 14683:2019+AC: 2019 Annex C Medical face masks - Requirements and test methods. | <6.0 $mmH_2O/cm^2$ | Sterile Ear loop Non-edging (PRS-WK002):<br>Lot 200401: 3.03 $mmH_2O/cm^2$<br>Lot 200407: 3.01 $mmH_2O/cm^2$<br>Lot 200413: 3.01 $mmH_2O/cm^2$<br><br>Non-sterile Ear loop Non-edging (PRS-WK017):<br>Lot 200401: 2.88 $mmH_2O/cm^2$<br>Lot 200405: 2.88 $mmH_2O/cm^2$<br>Lot 200407: 2.85 $mmH_2O/cm^2$ |
| Flammability | The test was performed in accordance with 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles. | Class 1 | Sterile Ear loop Edging (PRS-WK001):<br>Lot 210522: Class 1<br>Lot 210706: Class 1<br>Lot 210812: Class 1<br><br>Sterile Ear loop Non-edging (PRS-WK002):<br>Lot 200401: Class 1<br>Lot 200407: Class 1<br>Lot 200413: Class 1<br><br>Sterile Headband Edging (PRS-WK003):<br>Lot 210522: Class 1<br>Lot 210706: Class 1<br>Lot 210812: Class 1 |

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| | Sterile Headband Non-edging<br>(PRS-WK004):<br>Lot 210522: Class 1<br>Lot 210706: Class 1<br>Lot 210812: Class 1<br><br>Sterile Tie-on (PRS-WK005):<br>Lot 210522: Class 1<br>Lot 210706: Class 1<br>Lot 210812: Class 1<br><br>Non-sterile Ear loop Edging<br>(PRS-WK016):<br>Lot 210817: Class 1<br>Lot 210819: Class 1<br>Lot 210823: Class 1<br><br>Non-sterile Ear loop Non-edging<br>(PRS-WK017):<br>Lot 200401: Class 1<br>Lot 200405: Class 1<br>Lot 200407: Class 1<br><br>Non-sterile Headband Edging<br>(PRS-WK018):<br>Lot 210817: Class 1<br>Lot 210819: Class 1<br>Lot 210823: Class 1<br><br>Non-sterile Headband Non-edging<br>(PRS-WK019):<br>Lot 210817: Class 1<br>Lot 210819: Class 1<br>Lot 210823: Class 1<br><br>Non-sterile Tie-on (PRS-WK020):<br>Lot 210817: Class 1<br>Lot 210819: Class 1<br>Lot 210823: Class 1 |
|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# 10. Clinical Test Conclusion

No clinical study is included in this submission.

- 11. Conclusion
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202843.