Procedure Mask with Ear Loops and Surgical Mask with Ties

K221134 · Safesource Direct, LLC · FXX · May 19, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221134
• Device Name: Procedure Mask with Ear Loops and Surgical Mask with Ties
• Applicant: Safesource Direct, LLC
• Product Code: FXX · General, Plastic Surgery
• Decision Date: May 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The SafeSource Direct Procedure Mask with Ear Loops is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodily fluids, and particulate material. These procedure masks are intended for use in infection control practices to reduce to blood and bodily fluid. The procedure masks are single use, disposable devices, provided non-sterile. The SafeSource Direct Surgical Mask with Ties is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodly fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. The surgical masks are single use, disposable devices, provided non-sterile.

Device Story

Device consists of flat-pleated, three-layer, non-sterile, single-use masks; available as Procedure Mask with ear loops or Surgical Mask with ties. Construction includes inner/outer spunbond polypropylene layers and middle meltblown polypropylene layer; features ethylene propylene copolymer coated aluminum nose wire for fit. Ear loops utilize spandex/elastane and polyester; ties utilize spunbond polypropylene. Used in clinical settings by healthcare personnel and patients to reduce exposure to blood, bodily fluids, and particulates. Provides physical barrier to microorganisms; aids in infection control. No electronic components or software.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100-19, ASTM F2101-19 (BFE), ASTM F2299 (PFE), ASTM F1862 (fluid resistance), and EN 14683 (differential pressure). Biocompatibility testing (cytotoxicity, irritation, sensitization) performed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Three-layer construction: spunbond polypropylene (inner/outer), meltblown polypropylene (middle). Nose wire: ethylene propylene copolymer coated aluminum. Ear loops: spandex/elastane and polyester. Ties: spunbond polypropylene. ASTM F2100-19 Level 1 and Level 3 performance. Non-sterile. Single-use. No software or energy source.

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 practices. Single-use, disposable, non-sterile.

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

• Procedure Mask, Surgical Mask (K202899)

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.

May 19, 2022

SafeSource Direct, LLC % Prithul Bom Most Repsonsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K221134

Trade/Device Name: Procedure Mask with Ear Loops and Surgical Mask with Ties Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 18, 2022 Received: April 19, 2022

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.

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

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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 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,

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K221134

#### Device Name

Procedure Mask with Ear Loops and Surgical Mask with Ties

#### Indications for Use (Describe)

The SafeSource Direct Procedure Mask with Ear Loops is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodily fluids, and particulate material. These procedure masks are intended for use in infection control practices to reduce to blood and bodily fluid. The procedure masks are single use, disposable devices, provided non-sterile.

The SafeSource Direct Surgical Mask with Ties is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodly fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. The surgical masks are single use, disposable devices, provided non-sterile.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <span style="display:inline-block; margin-right: 5px;">☐</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display:inline-block; margin-right: 5px;">☑</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

Version: 2

K221134

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

## Submitter Information

| Company: | Robbie Wicks |
|------------------------|--------------------------------------------------------------|
| | Vice President / COO |
| | SafeSource Direct, LLC |
| | 200 St Nazaire Rd. |
| | Broussard, LA 70518 United States |
| | Telephone: [phone] |
| | Fax: [phone] |
| | [e-mail]) |
| Contact: | Robbie Wicks |
| | Vice President / COO |
| | SafeSource Direct, LLC |
| | 200 St Nazaire Rd. |
| | Broussard, LA 70518 United States |
| | Telephone: [phone] |
| | Fax: [phone] |
| | [e-mail]) |
| Date Summary Prepared: | April 12, 2022 |
| Trade Name: | Procedure Mask with Ear Loops and Surgical Mask<br>with Ties |
| Common Name: | Mask, surgical |
| Classification Name: | Surgical apparel |
| Review Panel: | General & Plastic Surgery (SU) |
| Regulation: | 878.4040 |
| Class: | Class II |
| Product Code: | FXX |

# Equivalence Claimed to Predicate Device

The Procedure Mask with Ear Loops and Surgical Mask with Ties is equivalent to the Procedure Mask, Surgical Mask (K202899), manufactured by Kenpax International Limited.

| Trade Name: | Procedure Mask / Surgical Mask |
|----------------------|--------------------------------|
| Common Name: | Surgical Mask |
| Classification Name: | Surgical Face Mask |
| Product Code: | FXX |

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## Device Description

The Procedure Mask with Ear Loops (PM3001, PM3003) is a non-sterile, single use, three-layer, flat-folded mask with ear loops, and a nose wire. The Procedure Mask with Ear Loops is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded ear loops made of spandex/elastane fiber and polyester filament keep the user's mouth and nose. The ethylene propylene copolymer coated aluminum nose wire allows the user to fit the mask around their nose.

The Surgical Mask with Ties (SM3001, SM3003) is a non-sterile, single use, three-layer, flat-folded mask with ties, and a nose wire. The Surgical Mask with Ties is constructed of inner and outer layers consisting of spunbond polypropylene and a middle layer of meltblown polypropylene. The welded polypropylene tie straps keep the mask close to the user's mouth and nose. The ethylene propylene coated aluminum nose wire allows the user to fit the mask around their nose.

| Substantial Equivalence Table | | |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Proposed Device: Procedure<br>Mask with Ear Loops and<br>Surgical Mask with Ties | Primary Predicate Device:<br>Procedure Mask, Surgical Mask<br>(K202899) |
| Intended Use | To protect both patients and<br>healthcare personnel from the<br>transfer of microorganisms, body<br>fluids, and particulate material. | To protect both patients and<br>healthcare personnel from the<br>transfer of microorganisms, body<br>fluids, and particulate material. |
| Indication for Use | The SafeSource Direct Procedure<br>Mask with Ear Loops is intended to<br>be worn to protect both the patient<br>and healthcare personnel from the<br>transfer of microorganisms, bodily<br>fluids, and particulate material.<br>These procedure masks are<br>intended for use in infection<br>control practices to reduce the<br>potential exposure to blood and<br>bodily fluid. The procedure masks<br>are single use, disposable devices,<br>provided non-sterile.<br>The SafeSource Direct Surgical<br>Mask with Ties is intended to be<br>worn to protect both the patient and<br>healthcare personnel from the<br>transfer of microorganisms, bodily<br>fluids, and particulate material.<br>These surgical masks are intended<br>for use in infection control<br>practices to reduce the potential<br>exposure to blood and bodily fluid.<br>The surgical masks are single use,<br>disposable devices, provided non- | The Procedure Masks/ Surgical<br>Masks are intended to be worn to<br>protect both the patient and<br>healthcare personnel from transfer<br>of microorganisms, body fluids,<br>and particulate material. These face<br>masks are intended for use in<br>infection control practices to<br>reduce the potential exposure to<br>blood and body fluids. This is a<br>single use, disposable device(s),<br>provided non-sterile. |
| | sterile. | |
| 510(k) No. | Pending | K202899 |
| Manufacturer | SafeSource Direct, LLC | Kenpax International Limited |
| Classification | Class II, FXX (21 CFR 878.4040) | Class II, FXX (21 CFR 878.4040) |
| Model Description | PM3001: Procedure Mask with Ear<br>Loops, ASTM Level 1<br>PM3003: Procedure Mask with Ear<br>Loops, ASTM Level 3<br>SM3001: Surgical Mask with Ties,<br>ASTM Level 1<br>SM3003: Surgical Mask with Ties,<br>ASTM Level 3 | 68-8506-G: Procedure Mask,<br>Earloop, ASTM Level 1<br>65-8508-G: Procedure Mask,<br>Earloop, ASTM Level 3<br>68-8536-B: Surgical Mask, Tie-on,<br>ASTM Level 1<br>68-8538-B: Surgical Mask, Tie-on,<br>ASTM Level 3 |
| Design Features | Ear Loops, Tie-on | Ear Loops, Tie-on |
| Mask Style | Flat Pleated | Flat Pleated |
| Outer Facing Layer | Blue spunbond (polypropylene)<br>Level 1: 25 gsm<br>Level 3: 25 gsm | Spunbond polypropylene<br>Level 1: 22 gsm<br>Level 3: 25 gsm |
| Middle Layer | White meltblown (polypropylene)<br>Level 1: 25 gsm<br>Level 3: 25 gsm | Melt-blown polypropylene<br>Level 1: 22 gsm<br>Level 3: 25 gsm |
| Inner Facing Layer | Blue spunbond (polypropylene)<br>Level 1: 25 gsm<br>Level 3: 25 gsm | Spunbond polypropylene<br>Level 1: 22 gsm<br>Level 3: 25 gsm |
| Nose Piece | Dual aluminum wire, white<br>ethylene propylene copolymer | Polyethylene coated steel wire |
| Ear Loops | White knitted spandex/elastane<br>fiber, polyester filament | Nylon, spandex |
| Tie-On | White spunbond (polypropylene) | Spunbond polypropylene |
| Color | Blue, White | Blue, Green |
| Dimension (Width) | 3.74" ± 0.40" | 95 ± 5 mm |
| Dimension (Length) | 6.89" ± 0.40" | 178 ± 5 mm |
| OTC Use | Yes | Yes |
| Sterility | Non-sterile | Non-sterile |
| Use | Single Use, Disposable | Single Use, Disposable |
| ASTM F2100 Level | Level 1, Level 3 | Level 1, Level 3 |
| Fluid Resistance | Meet ASTM F1862/F1862M-17 | Meet ASTM F1862-17 |
| Particulate Filtration Efficiency<br>(PFE) | Meet ASTM F2299/F2299M-03<br>(2017) | Meet ASTM F2299-17 |
| Bacterial Filtration<br>(BFE) | Efficiency | |
| | Meet ASTM F2101-19 | Meet ASTM F2101-19 |
| Differential Pressure | Meet EN 14683:2019+AC:2019<br>Annex C | Meet EN 14683:2019, Annex C |
| Flammability | Meet 16 CFR 1610 (Oct 2008) | Meet 16 CFR 1610 |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Irritation | Negligibly irritating (Primary<br>Irritation Index 0.0) | Non-irritating |
| Sensitization | Not a contact sensitizer | Non-sensitizing |

#### Substantial Equivalence Comparison

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# K221134
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#### Additional Information

#### Summary of Non-Clinical Testing Conducted

Non-clinical testing was conducted to verify the proposed device meets the same design specifications as the predicate device. Test results demonstrated the proposed device complies with the requirements of US FDA Guidance for Industry and FDA Staff / Surgical Masks - Premarket Notification [510(k)] Submissions posted on July 14, 2004 and the following standards:

- · ASTM F2100-19, Standard Specification for Performance of Materials Used In Medical Face Masks
- · ASTM F2101-19, 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 + AC:2019 Annex C, Medical Face Masks-Requirements and Test Methods
- · ASTM F2299/F2299M-03(2017), Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- · 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)
- · 16 CFR 1610, Standard for the Flammability of Clothing Textiles
- · ISO 10993-5: 2009, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity, and
- · ISO 10993-10: 2010, Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin Sensitization.

Tables 1 and 2 summarize the performance test data.

| Table 1 Comparison of Performance Testing for Proposed ASTM Level 1 Procedure<br>Mask with Ear Loops (PM3001) and Surgical Mask with Ties (SM3001) with Predicate | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|--------------------|----------------------------------|--------------------|----------------------------------|
| Device | | | | | |
| Non-Clinical<br>Test | Acceptance<br>Criteria<br>(ASTM<br>Level 1) | Proposed<br>Device | Predicate<br>Device<br>(K202899) | Proposed<br>Device | Predicate<br>Device<br>(K202899) |
| | | PM3001 | 68-8506-G | SM3001 | 68-8536-B |

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K221134 Page 5 of 6

| Fluid<br>Resistance | ≥ 29 of 32<br>pass at 80<br>mmHg | Pass (96/96)<br>at 80 mmHg,<br>32 samples<br>from 3 non-<br>consecutive<br>lots | 32 of 32<br>passed at 80<br>mmHg, 3 lots | Pass (96/96)<br>at 80 mmHg,<br>32 samples<br>from 3 non-<br>consecutive<br>lots | 32 of 32<br>passed at 80<br>mmHg, 3 lots |
|-----------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------|
| Particulate<br>Filtration<br>Efficiency | ≥ 95% at 0.1<br>micron | Pass (96/96)<br>at > 95%,<br>32 samples<br>from 3 non-<br>consecutive<br>lots | 97.4%,<br>97.5%,<br>97.5% | Pass (96/96)<br>at > 95%,<br>32 samples<br>from 3 non-<br>consecutive<br>lots | 97.2%,<br>97.1%,<br>97.1% |
| Bacterial<br>Filtration<br>Efficiency | ≥ 95% | Pass (96/96)<br>at > 95%, 32<br>samples from<br>3 non-<br>consecutive<br>lots | 99.9%, 3 lots | Pass (96/96)<br>at > 95%, 32<br>samples from<br>3 non-<br>consecutive<br>lots | 99.9%, 3 lots |
| Differential<br>Pressure | < 5.0<br>mmH2O/cm2 | Pass (96/96)<br>at < 5.0<br>mmH2O/cm²,<br>32 samples<br>from 3 non-<br>consecutive<br>lots | 2.9, 2.8, 2.7<br>mmH20/cm² | Pass (95/96)<br>at < 5.0<br>mmH2O/cm²,<br>32 samples<br>from 3 non-<br>consecutive<br>lots | 3.7, 3.4, 3.7<br>mmH20/cm² |
| Flammability | Class 1 | Pass (96/96)<br>at Class 1, 32<br>samples from<br>3 non-<br>consecutive<br>lots | Class 1 | Pass (96/96)<br>at Class 1, 32<br>samples from<br>3 non-<br>consecutive<br>lots | Class 1 |
| Cytotoxicity | | Non-<br>cytotoxic | Non-cytotoxic | Non-<br>cytotoxic | Non-cytotoxic |
| Irritation | | Negligibly<br>irritating<br>(Primary<br>Irritation<br>Index 0.0) | Non-irritating | Negligibly<br>irritating<br>(Primary<br>Irritation<br>Index 0.0) | Non-irritating |
| Sensitization | | Not a contact<br>sensitizer | Non-<br>sensitizing | Not a contact<br>sensitizer | Non-<br>sensitizing |

### Table 2 Comparison of Performance Testing for Proposed ASTM Level 3 Procedure Mask with Ear Loops (PM3003) and Surgical Mask with Ties (SM3003) with Predicate Device

| Non-Clinical<br>Test | Acceptance<br>Criteria<br>(ASTM<br>Level 3) | Proposed<br>Device | Predicate<br>Device<br>(K202899) | Proposed<br>Device | Predicate<br>Device<br>(K202899) |
|-----------------------------------|---------------------------------------------|-------------------------------------------------------------------------|-------------------------------------|-------------------------------------------------------------------------|-------------------------------------|
| | | PM3003 | 68-8508-G | SM3003 | 68-85368-B |
| | | | | | |
| Fluid Resistance | ≥ 29 of 32 pass at 160 mmHg | Pass (96/96) at 160 mmHg, 32 samples from 3 non-consecutive lots | 32 of 32 passed at 160 mmHg, 3 lots | Pass (96/96) at 80 mmHg, 32 samples from 3 non-consecutive lots | 32 of 32 passed at 160 mmHg, 3 lots |
| Particulate Filtration Efficiency | ≥ 98% at 0.1 micron | Pass (95/96) at > 98%, 32 samples from 3 non-consecutive lots | 98.2%, 98.4%, 98.4% | Pass (95/96) at > 98%, 32 samples from 3 non-consecutive lots | 98.4%, 98.4%, 98.3% |
| Bacterial Filtration Efficiency | ≥ 98% | Pass (96/96) at > 98%, 32 samples from 3 non-consecutive lots | 99.9%, 3 lots | Pass (96/96) at > 98%, 32 samples from 3 non-consecutive lots | 99.9%, 3 lots |
| Differential Pressure | < 6.0 mmH2O/cm2 | Pass (96/96) at < 6.0 mmH2O/cm2, 32 samples from 3 non-consecutive lots | 3.4, 3.0, 3.0 mmH2O/cm² | Pass (96/96) at < 6.0 mmH2O/cm2, 32 samples from 3 non-consecutive lots | 4.1, 3.4, 3.4 mmH2O/cm2 |
| Flammability | Class 1 | Pass (96/96) at Class 1, 32 samples from 3 non-consecutive lots | Class 1 | Pass (96/96) at Class 1, 32 samples from 3 non-consecutive lots | Class 1 |
| Cytotoxicity | | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic |
| Irritation | | Negligibly irritating (Primary Irritation Index 0.0) | Non-irritating | Negligibly irritating (Primary Irritation Index 0.0) | Non-irritating |
| Sensitization | | Not a contact sensitizer | Non-sensitizing | Not a contact sensitizer | Non-sensitizing |

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#### Summary of Clinical Testing Conducted

No clinical testing is included in this submission.

#### Substantial Equivalence Conclusion

Based on comparison of the subject device to the predicate device and the non-clinical tests performed, it can be concluded that the proposed Procedure Mask with Ear Loops and Surgical Mask with Ties are as safe and effective, and perform as well as the legally marketed predicate device Kenpax International Limited Procedure Mask/Surgical Mask cleared under premarket notification K202899.

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