Altor Safety 4-Ply Surgical Mask (Model:62232)

K211762 · Altor Safety, LLC · FXX · Sep 3, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211762
• Device Name: Altor Safety 4-Ply Surgical Mask (Model:62232)
• Applicant: Altor Safety, LLC
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Sep 3, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Altor Safety 4-Ply Surgical Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 4-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non- sterile, disposable device.

Device Story

Flat-pleated 4-ply surgical mask; features ear loops and nose piece for facial fit. Construction: 2 outer layers of spunbond polypropylene; middle layer of melt-blown polypropylene; inner layer of spunbond polypropylene; spandex/nylon ear loops; polyethylene/steel/paper nose wire. Used in clinical settings by healthcare personnel and patients for infection control. Acts as physical barrier to microorganisms, body fluids, and particulates. Protects wearer and patient from cross-contamination. Non-sterile, single-use, disposable.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM F2101 (BFE 99.60%), ASTM F2299 (PFE ≥99%), ASTM F1862 (fluid resistance 160 mmHg), and EN 14683 (Delta P 3.5 mmH2O/cm2). Biocompatibility confirmed per ISO 10993-1, -5, and -10.

Technological Characteristics

4-layer nonwoven polypropylene construction; ASTM F2100 Level 3 compliant. Materials: Spunbond/Melt-blown polypropylene, spandex/nylon ear loops, polyethylene/steel/paper nose wire. Dimensions: 92mm width, 171.45-177.8mm length. Non-sterile, single-use, disposable. No software or electronic components.

Indications for Use

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

• Cardinal Health™ Level 3 Surgical Mask (K192374)

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

September 3, 2021

Altor Safety LLC % Dallas Thomas Medical Device Regulatory Consultant Thomas Regulatory Resolutions, Inc. 1069 Piccadilly St. Palm Beach Gardens, Florida 33418

Re: K211762

Trade/Device Name: Altor Safety 4-Ply Surgical Mask (Model: 62232) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 2, 2021 Received: June 8, 2021

Dear Dallas Thomas:

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 and Part 809 ); medical device reporting (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,

For Clarence Murray III, Ph.D. Acting 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) K211762

Device Name Altor Safety 4-Ply Surgical Mask (Model: 62232)

Indications for Use (Describe)

The Altor Safety 4-Ply Surgical Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 4-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non- sterile, disposable device.

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

| <input type="checkbox"/> Research Use Only (314 CFR 201.3(x)) Statement | <input checked="true" type="checkbox"/> <i>In-Vitro</i> Sensitivity (314 CFR 201.3(s)) Statement |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|

__ 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

### K211762

This summary of 510(k) is being submitted in accordance with requirements of 21 CFR 807.92.

#### 5.1 General Information

Preparation Date: 2 August 2021

### Submitter/Holder

Jared Scott Operations Manager Altor Safety LLC 711 Executive Boulevard Suite C, Valley Cottage, NY, USA 10989 Contact Phone#: [phone] Contact Email: [e-mail]

Primary Submission Contact

Dallas L. Thomas, RAC, MHA, MPA, SSYB Medical Device Regulatory Consultant Thomas Regulatory Resolutions 1069 Piccadilly St. Palm Beach Gardens, FL 33418 Mobile [phone] Email: [e-mail]

#### 5.2 Regulatory Information

### Subject Device

| Subject Device Name | Altor Safety 4-Ply Surgical Mask (Model:62232) |
|-----------------------|------------------------------------------------|
| Classification Names | Surgical apparel. |
| Device Classification | II |
| Common Name | Altor Safety 4-Ply Surgical Mask |
| FDA Product Code | FXX |

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| CFR References | 21 CFR 878.4040 |
|----------------|------------------|
| Review Panel | General Hospital |

### Identification of Predicate Device:

| Predicate Device Name | K192374 |
|-----------------------|----------------------------------------|
| Classification Names | Surgical apparel. |
| Device Classification | II |
| Common Name | Cardinal Health™ Level 3 Surgical Mask |
| FDA Product Code | FXX |
| CFR References | 21 CFR 878.4040 |
| Review Panel | General Hospital |

#### 5.3 Subject Device Description

The Altor Safety 4-Ply Surgical Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The mask outward facing layer is blue in color, using color master batch.

The device is manufactured with 4 layers: 2-Outer Facing Layers: Spunbond nonwoven polypropylene (Blue), Middle Layer: Melt Blown nonwoven polypropylene (White) and Inner Layer: Spunbond nonwoven polypropylene (White). Other Materials used include the Ear loops which are made from Spandex / Nylon. The subject device is provided non-sterile and is a single use, disposable device.

#### Subject Device Specification 5.4

Design specifications:

- Size/Dimensions:

| Mask Dimensions-Width | 3.625in (92 mm) |
|-----------------------|-----------------|
|-----------------------|-----------------|

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| Mask Dimensions-Length | 6.75-7.00in (171.45 mm-177.8mm ) |
|------------------------|------------------------------------------------|
| Ear Loops Dimensions | Length: .7 inches per each individual ear loop |

- ASTM Level 3
- Product model number: 62232 ●
- Materials of subject device are as listed below. ●

| 2 Outer Facing Layers (Blue) | Spunbond nonwoven polypropylene |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Outer Layer (Blue) | Spunbond nonwoven polypropylene |
| Middle Layer (White) | Melt blown nonwoven polypropylene |
| Inner Layer (White) | Spunbond nonwoven polypropylene |
| Nose Wire | Virgin polyethylene plastic, 24 gauge<br>soft annealed carbon steel, and kraft paper<br>(nominal basis weight of 25 lbs. /ream) |
| Ear Band / Loop | Spandex / Nylon |

#### ર્સ્ડ Indications for Use

The Altor Safety 4-Ply Surgical Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 4-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, nonsterile, disposable device.

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### 5.6 Summary of Technological Characteristics

# Table 1. Summary Comparison of Characteristics

| Device Characteristic | Proposed Subject<br>Device | Primary Predicate<br>Device | Comparison<br>Analysis: |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Product Name | Altor Safety 4-Ply<br>Surgical Mask | Cardinal Health™<br>Level 3 Surgical<br>Mask With Anti-<br>Fog Foam Strip | Different |
| Manufacturer | Altor Safety | Cardinal Health 200,<br>LLC | Different |
| FDA Product Code | FXX | FXX | Same |
| CFR Reference | 878.4040 | 878.4040 | Same |
| Device Class | II | II | Same |
| 510(k) reference | k211762 | K192374 | N/A |
| | | | Similar, |
| Indications for use<br>statement | The Altor Safety 4-<br>Ply Surgical Mask is<br>intended to be worn<br>to protect both the<br>patient and<br>healthcare | The Cardinal<br>Health™ Level 3<br>surgical masks with<br>Anti-Fog Foam Strip<br>are intended to be<br>worn by operating | Similar, minor<br>wording differences<br>do not impact safety<br>or efficacy. |
| Device Characteristic | Proposed Subject<br>Device | Primary Predicate<br>Device | Comparison<br>Analysis: |
| | professional from<br>transfer of<br>microorganisms,<br>body fluids, and<br>particulate material.<br>The Altor Safety 4-<br>Ply Surgical Mask is<br>intended for use in<br>infection control<br>practices to reduce<br>the potential<br>exposure to blood<br>and body fluids. This<br>is a single use, non-<br>sterile, disposable<br>device. | room personnel and<br>other general<br>healthcare workers<br>to protect both<br>patients and<br>healthcare workers<br>against transfer of<br>microorganisms,<br>blood and body<br>fluids, and airborne<br>particulates. The<br>Cardinal Health™<br>Level 3 surgical<br>masks are single use,<br>disposable devices<br>provided non-sterile. | |
| Device Generic Raw<br>Materials | 2 Outer Facing<br>Layers: Spunbond<br>nonwoven<br>polypropylene<br><br>Middle Layer: Melt<br>Blown nonwoven<br>polypropylene filter<br><br>Inner facing layer:<br>Spunbond nonwoven<br>polypropylene<br><br>Ear loop: Spandex /<br>Nylon | Spunbond<br>Polypropylene<br><br>Melt Blown<br>Polypropylene Filter<br><br>Ear loop: Spandex /<br>Nylon<br><br>Nose Wire -plastic, | Similar materials<br>based on publicly<br>available details |
| Device Characteristic | Proposed Subject<br>Device | Primary Predicate<br>Device | Comparison<br>Analysis: |
| | Nose Wire - Virgin<br>polyethylene plastic,<br>24 gauge<br>soft annealed carbon<br>steel, and kraft paper<br>(nominal basis<br>weight of 25 lbs.<br>/ream) | | |
| Color (outward facing<br>Layer) | Blue | White | Different - |
| Patient Anatomical<br>Site for Use of Device | Nose and Mouth | Nose and Mouth | Same |
| Mode of Operation | Protective Mask | Protective Mask | Same |
| Reusable or Single<br>Use | Single Use | Single Use | Same |
| Sold Sterile or Non-<br>Sterile | Non-Sterile | Non-Sterile | Same |
| Prescription Status | OTC | OTC | Same |
| Fluid Resistance<br>Performance ASTM<br>F1862-13 | 32 out of 32 pass at<br>160mmHg | 31 out of 32 pass at<br>120mmHg | Similar |
| Particulate Filtration<br>Efficiency ASTM<br>F2299 | ≥99% | ≥98% | Similar |

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| Device Characteristic | Proposed Subject<br>Device | Primary Predicate<br>Device | Comparison<br>Analysis: |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Bacterial Filtration<br>Efficiency ASTM<br>F2101 | 99.60% | ≥ 98% | Similar- |
| Differential Pressure<br>(Delta P) EN 14683 | 3.5mmH 2 0/cm 2<br>(The average of 3<br>lots with means of<br>4.2,3.2 and 3.1)) | < 5.0 mm H 2 O/cm<br>2 | Similar |
| Flammability 16 CFR<br>1610 | Class 1 | Class 1 | Same |
| Cytotoxicity | Under the conditions<br>of the study, the<br>proposed device<br>extract was<br>determined to be<br>non-cytotoxic. | Under the conditions<br>of the study, the<br>proposed device<br>extract was<br>determined to be<br>non-cytotoxic. | Same |
| Irritation | Under the conditions<br>of the study, the<br>proposed device<br>non-polar and polar<br>extracts were<br>determined to be<br>non-irritating. | Under the conditions<br>of the study, the<br>proposed device<br>non-polar and polar<br>extracts were<br>determined to be<br>non-irritating. | Same |
| Sensitization | Under the conditions<br>of the study, the<br>proposed device<br>non-polar and polar<br>extracts were<br>determined to be<br>non-sensitizing. | Under the conditions<br>of the study, the<br>proposed device<br>non-polar and polar<br>extracts were<br>determined to be<br>non-sensitizing. | Same |

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| Device Characteristic | Proposed Subject<br>Device | Primary Predicate<br>Device | Comparison<br>Analysis: |
|-----------------------|-------------------------------------|-----------------------------|-------------------------|
| Dimensions-Width | 3.625in (92 mm) | 4in | Similar |
| Dimensions-Length | 6.75-7.00in (171.45<br>mm-177.8mm ) | 7 in | Similar - |
| ASTM F2100 Level | Level 3 | Level 3 | Same |

### Summary of Non-Clinical Performance Testing 5.7

| Test Method | Purpose | Pass Criteria | Results |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------------------------------------------------------------------|
| ASTM F2101-19Standard<br>Test Method for<br>Evaluating the Bacterial<br>Filtration | The purpose of the test is to<br>evaluate the Bacterial filtration<br>efficiency (BFE) (%) | ≥98% | 3 lots tested with<br>total 96 samples,<br>94/96 Passed at<br>≥98% /Pass |
| EN 14683: 2019, Annex<br>C Medical face masks -<br>Requirements and<br>test methods according to<br>ASTM F2100:2019 | The purpose of the test is to<br>evaluate the Different pressure<br>(Delta-P) | <6.0<br>mmH2O/cm² | 3 lots tested with<br>total 96 samples,<br>92/96 Passed<br><6 mmH2O/cm²<br>/ Pass |
| ASTM F2299-03<br>Standard Test Method for<br>Determining the Initial<br>Efficiency of Materials<br>Used in Medical Face<br>Masks to Penetration by<br>Particulates Using Latex<br>Spheres according to<br>ASTME2100:2019 | The purpose of the test is to<br>evaluate the Sub-micron<br>particulate filtration efficiency<br>at 0.1 micron, % (PFE) | ≥98% | 3 lots tested with<br>total 96 samples,<br>96/96 Passed at<br>≥98% / Pass |

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| ASTM F1862M-17<br>Standard Test Method for<br>Resistance of Medical<br>Face Masks to<br>Penetration by Synthetic<br>Blood (Horizontal<br>Projection of Fixed<br>Volume at a Known<br>Velocity) according to<br>ASTMF2100:2019for<br>pass result | The purpose of the test is to<br>evaluate the Resistance to<br>penetration by synthetic blood,<br>Minimum pressure in mmHg | Fluid<br>resistant<br>claimed at<br>160 mm Hg | 3 lots tested with<br>total 96 samples,<br>95 of 96 test articles<br>passed at 160mmHg<br>/Pass |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------------------------------------------------------------------|
| 16 CFR Part 1610 Standard<br>for the Flammability of<br>Clothing according to<br>ASTM F2100:2019 | The purpose of the test is to<br>evaluate the Flame spread | Class 1 | 3 lots tested with<br>total 96 samples,<br>96/96 Passed ≥3<br>seconds burn Time-<br>Class 1 /<br>Pass |

- . Biocompatibility Testing According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use: per ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity,
- 1) Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization,
- 2) Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation

of medical devices- Part 10: Tests for irritation and skin sensitization.

#### 5.8 Summary of Clinical Performance Testing

No clinical study is included in this submission

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#### 5.9 Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K211762, the Altor Safety 4-Ply Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device, cleared under K192374.