Sovereign America Surgical Mask is intended for use by healthcare personnel to protect both patients and healthcare personnel against the transfer of microorganisms, bodily fluids and particulate material. This is a single use, disposable device, provided non-sterile.

Device Description

The Sovereign America Surgical Mask is a single use, three-layer, flatpleated surgical mask with ear loops and a nose piece. The device is composed of three layers of nonwoven polypropylene, with the outer layer (Layer 1) and inner layer (Layer 3) being spun-bond nonwoven polypropylene, and the middle layer (Layer 2) being melt-blown nonwoven polypropylene. Layer 1 contains a blue pigment. The device utilizes two elastic ear loops, ultrasonically welded to the mask, to hold the device in place over the users' mouth and nose. The ear loops are polyester spandex elastic, and not made with natural rubber latex. The device also utilizes a malleable nose piece, made of polypropylene coated aluminum wire, to allow the user to fit the device around the bridge of the nose. The mask is provided non-sterile and intended to be a single use, disposable device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Sovereign America Surgical Mask (K201095), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Testing Standard	Acceptance Criteria (ASTM F2100 Level 1)	Sovereign America Surgical Mask (K201095) Performance
Fluid Resistance (ASTM F1862)	29 out of 32 passed at 80 mmHg	29 out of 32 passed at 80 mmHg
Bacterial Filtration Efficiency (ASTM F2101)	≥ 95%	99.1 - 99.8%
Particulate Filtration Efficiency (ASTM F2299)	≥ 95%	99.55 - 99.91%
Differential Pressure (EN 14683/MIL-M-36954C)	< 5.0 mm H2O/cm²	2.5 - 3.3 mm H2O/cm²
Flammability (16 CFR 1610)	Class 1	Class 1
Cytotoxicity (MEM Elution) (ISO 10993-5:2009)	Non-Cytotoxic	Pass (Non-Cytotoxic)
Intracutaneous Reactivity (ISO 10993-10:2010)	Non-Irritating	Pass (Non-Irritating)
Kligman Maximization Sensitization (ISO 10993-10:2010)	Non-Sensitizing	Pass (Non-Sensitizing)

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical testing in conformity with recognized consensus standards. It does not specify sample sizes for each individual test conducted on the Sovereign America Surgical Mask. The results presented (e.g., "29 out of 32 passed") indicate the sample size for the fluid resistance test was 32. For the other tests, while a range is given for some (e.g., "99.1 - 99.8%"), the exact number of samples tested to achieve these ranges is not explicitly stated.

The data provenance is based on laboratory testing of the device itself; thus, it is prospective in the sense that the testing was performed on the manufactured device. There is no information regarding the country of origin of the data beyond the standards themselves being international (e.g., ASTM, ISO, EN, CFR) and the submission being to the U.S. FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not applicable to this type of device and study. The "ground truth" for surgical mask performance is established by the specified measurable parameters and pass/fail criteria outlined in the referenced consensus standards (e.g., ASTM F2100, ASTM F1862, ISO 10993). These are objective, quantifiable measurements performed according to standardized protocols, not subjective expert assessment.

4. Adjudication Method for the Test Set:

This is not applicable. As the testing involves objective measurements against established standards, there is no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI or diagnostic imaging devices where human readers assess cases. For a surgical mask, the effectiveness is determined by its physical performance characteristics.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable to a surgical mask. It's a physical device, not an algorithm or AI system. The performance evaluated is the inherent physical properties of the mask.

7. The Type of Ground Truth Used:

The ground truth used for this study is based on objective, measurable criteria defined by recognized consensus standards. These standards set specific thresholds for fluid resistance, filtration efficiency, differential pressure, flammability, and biocompatibility. The mask's performance is then directly compared against these predefined numerical and qualitative thresholds.

8. The Sample Size for the Training Set:

This question is not applicable. This is a physical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

This question is not applicable as there is no training set for a physical surgical mask.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

March 19, 2021

Homtex, Inc. Jeremy Wootten President and CFO 2125 2nd Avenue SW Cullman, Alabama 35055

Re: K201095

Trade/Device Name: Sovereign America Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 11, 2021 Received: February 26, 2021

Dear Jeremy Wootten:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ryan Ortega, 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201095

Device Name

Sovereign America Surgical Mask, Model: 2000SM1

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows a logo for Sovereign America. The logo features a shield with a red cross in the center and a blue upper portion. Above the shield is the text "SOVEREIGN AMERICA" in a bold, sans-serif font. Below the text is an image of the American flag and the words "MADE IN USA".

510(K) SUMMARY

This 510(K) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Preparation Date:

March 17, 2021

2. Submitter:

Homtex, Inc. 2125 2nd Avenue SW Cullman AL 35055 Phone: 256-734-3937 Fax: 256-734-2043

Contact: Jeremy Wooten, President and CFO Email: jeremy.wootten@homtex.com

3. Proposed Device:

Trade Name:	Sovereign America Surgical Mask, Model 2000SM1
Common Name:	Surgical Mask
Regulation Number:	21 CFR 878.4040
Classification:	Class II
Product Code:	FXX

4. Predicate Device:

510(k) Number:	K153409
Trade Name:	Protect U Guard Earloop Mask and Tie-On
Common Name:	Surgical Mask
Regulation Number:	21 CFR 878.4040
Regulatory Class:	Class II
Product Code:	FXX

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5. Device Description:

Intended Use: 6.

Comparison to Predicate Device: 7.

Item	Proposed Device	Predicate Device	Comparison
Manufacturer	Homtex, Inc.	Protect U Guard, LLC
Product Code	FXX	FXX	Same
Classification andRegulation	Class II21 CFR878.4040	Class II21 CFR878.4040	Same
Intend use	The Sovereign AmericanSurgical Mask is intended foruse by healthcare personnel toprotect both patients andhealthcare personnel againstthe transfer ofmicroorganisms, bodily fluidsand particulate material. Thisis a single use, disposabledevice, provided non-sterile.	The Protect U Guard EarloopMask and Tie-On Mask isintended for use byhealthcare workers duringprocedures to protect bothpatients and healthcareworkers against transfer ofmicroorganisms, bodily fluidsand airborne particles. Thisdevice is single use andprovided non-sterile.	Similar

Table 1: General Comparison

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Model Style		Flat-pleatedearloops	Flat pleatedEarloops or tie-on	Same
Material	Outer layer	Spunbond nonwovenpolypropylene	Spunbound polypropylene	Same
	Middle layer	Melt-blown nonwovenpolypropylene	Meltblown polypropylene	Same
	Inner layer	Spunbond nonwovenpolypropylene	Spunbound polypropylene	Same
	Nose Piece	Polypropylene coatedaluminum wire	Aluminum strip	Similar
	Ear loops	Polyester spandex elastic	Urethane elastic fiber	Similar
Color		Blue	Blue, White, or Green	Similar
Dimension (Width)		17.5 cm	17.7 cm	Similar
Dimension (Length)		9.5 cm	9.5 cm	Same
OTC use		Yes	Yes	Same
Sterility		Non-Sterile	Non-Sterile	Same
Use		Single Use, Disposable	Single Use, Disposable	Same
Latex		Not Made with NaturalRubber Latex	Not Made with NaturalRubber Latex	Same
Performance (ASTM F2100 Level 1)
Fluid Resistance(ASTM F1862)		29 out of 32 passed at 80 mmHg	29 out of 32 passed at 80 mmHg	Same
Bacterial FiltrationEfficiency(ASTM F2101)		99.1 - 99.8%	99.17%	Similar
Particulate FiltrationEfficiency(ASTM F2299)		99.55 - 99.91 %	99.18%	Similar
Differential Pressure(EN 14683/MIL-M-36954C)		2.5 - 3.3 mm H2O/cm²	3.79 mm H2O/cm²	Similar
Flammability(16 CFR 1610)		Class 1	Class 1	Same
Biocompatibility
Cytotoxicity(MEM Elution)ISO 10993-5:2009		Non-Cytotoxic	Non-Cytotoxic	Same
IntracutaneousReactivityISO 10993-10:2010		Non-Irritating	Non-Irritating	Same

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Non-Clinical Testing: 8.

Sovereign America Surgical Mask has been tested in conformity with the recognized consensus standards outlined in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions issued on March 5, 2004 and in ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks, including performance tests for 1) fluid resistance; 2) bacterial filtration efficiency; 3) particulate filtration efficiency; 4) differential pressure; and 5) flammability as well as biocompatibility tests. The performance testing and biocompatibility testing results showed that Sovereign America Surgical Mask passed all acceptance criteria in the consensus standards as set forth in the Tables 2 and 3 below.

Table 2: Performance Testing

Testing Standards	Acceptance CriteriaASTM F2100 Level 1	Sovereign AmericaSurgical Mask(K201095)	Predicate Device(K153409)
Fluid Resistance(ASTM F1862)	29 out of 32 passed at80 mmHg	29 out of 32 passed at80 mmHg	29 out of 32 passedat 80 mmHg
Bacterial FiltrationEfficiency(ASTM F2101)	≥ 95%	99.1 - 99.8%	99.17%
Particulate FiltrationEfficiency(ASTM F2299)	≥ 95%	99.55 - 99.91 %	99.18%
Differential Pressure(EN 14683/MIL-M-36954C)	< 5.0 mm H2O/cm2	2.5 - 3.3 mm H2O/cm2	3.79 mm H2O/cm2
Flammability (16CFR 1610)	Class 1	Class 1	Class 1

	Table 3: Biocompatibility Testing

Testing Items	Standards	Results
Cytotoxicity (MEM Elution)	ISO 10993-5:2009	Pass (Non-Cytotoxic)
Intracutaneous Reactivity	ISO 10993-10:2010	Pass (Non-Irritating)
Kligman Maximization Sensitization	ISO 10993-10:2010	Pass (Non-Sensitizing)

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9. Conclusion:

The nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate K153409.

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
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.(b)
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.