K Number
K211066
Device Name
Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3
Manufacturer
Date Cleared
2021-08-19

(129 days)

Product Code
Regulation Number
878.4040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sovereign America Surgical Mask is intended for use by adult patients and healthcare personnel to protect against the transfer of microorganisms, bodily fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
Device Description
The Sovereign America Surgical Mask, Models 2000SM2 and 2000SM3, is a single use, three-layer, flat-pleated surgical mask with ear loops and a nose piece. Each 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. Each 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. Each 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. Each is provided non-sterile and intended to be a single use, disposable device.
More Information

Not Found

No
The device description and performance studies focus on the physical properties and filtration efficiency of a surgical mask, with no mention of AI or ML technology.

No.
The device is described as a surgical mask intended to protect against the transfer of microorganisms, bodily fluids, and particulate material, and for use in infection control practices, rather than for treating or curing a medical condition.

No

Explanation: The device is a surgical mask intended to protect against the transfer of microorganisms, bodily fluids, and particulate material, and for use in infection control practices. It does not perform any diagnostic function.

No

The device description clearly outlines a physical, multi-layer surgical mask made of nonwoven polypropylene with ear loops and a nose piece. The performance studies focus on physical properties like fluid resistance and filtration efficiency, not software performance.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, bodily fluids, and particulate material, and for use in infection control practices. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
  • Device Description: The description details the physical construction of a surgical mask, focusing on materials and how it's worn. There is no mention of reagents, samples, or any components used for analyzing biological specimens.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring specific substances (analytes)
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions.
  • Performance Studies: The performance studies focus on the physical properties and filtration capabilities of the mask (fluid resistance, filtration efficiency, breathability, flammability), which are relevant to its function as a barrier, not as a diagnostic tool.

In summary, the Sovereign America Surgical Mask is a medical device intended for personal protection and infection control, not for performing diagnostic tests on biological samples.

N/A

Intended Use / Indications for Use

Sovereign America Surgical Mask is intended for use by adult patients and healthcare personnel to protect against the transfer of microorganisms, bodily fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

Product codes (comma separated list FDA assigned to the subject device)

FXX

Device Description

The Sovereign America Surgical Mask, Models 2000SM2 and 2000SM3, is a single use, three-layer, flat-pleated surgical mask with ear loops and a nose piece. Each 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. Each 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. Each 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. Each is provided non-sterile and intended to be a single use, disposable device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult patients

Intended User / Care Setting

healthcare personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing: Sovereign America Surgical Mask, Models 2000SM2 and 2000SM3, 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, Models 2000SM2 and 2000SM3, passed all acceptance criteria in the consensus standards as set forth in Tables 2, 3, and 4 below.

Table 2: Performance Testing - Sovereign America Surgical Mask Model 2000SM2

Testing StandardsAcceptance Criteria ASTM F2100 Level 2Sovereign America Surgical Mask Model 2000SM2Predicate Device (K160269)Result
Fluid Resistance (ASTM F1862)29/32 pass at 120 mm Hg32/32 pass at 120 mm HgPass at 120 mm HgMeets or exceeds acceptance criteria
Bacterial Filtration Efficiency (ASTM F2101)≥ 98%99.1 - 99.9%≥ 98%Meets or exceeds acceptance criteria
Particulate Filtration Efficiency (ASTM F2299)≥ 98%99.55 - 99.91 %99.6%Meets or exceeds acceptance criteria
Differential Pressure (EN 14683/MIL-M-36954C)

§ 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.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 19, 2021

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

Re: K211066

Trade/Device Name: Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 16, 2021 Received: July 19, 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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K211066

Device Name

Sovereign America Surgical Mask, Model: 2000SM2

Indications for Use (Describe)

Sovereign America Surgical Mask is intended for use by adult patients and healthcare personnel to protect against the transfer of microorganisms, bodily fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

Type of Use (Select one or both, as applicable)
-------------------------------------------------
Prescription Use (Part 801, Subpart D)
Over-The-Counter Use (81 CFR 801, Subpart C)

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Indications for Use

510(k) Number (if known) K211066

Device Name

Sovereign America Surgical Mask, Model: 2000SM3

Indications for Use (Describe)

Sovereign America Surgical Mask is intended for use by adult patients and healthcare personnel to protect against the transfer of microorganisms, bodily fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

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

☐ Registration Use (Part 31 CFR 901.2, Subpart B)☑ One-Time-Coverage (31 CFR 901.2, Subpart C)
--------------------------------------------------------------------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

Image /page/4/Picture/0 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. Below the shield, the words "SOVEREIGN AMERICA" are written in a simple font. Underneath the text, there is an image of an American flag and the words "MADE IN USA".

510(K) SUMMARY K211066

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

1. Preparation Date:

August 10, 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

Proposed Devices: 3.

510(k) Number:K211066
Trade Name:Sovereign America Surgical Mask, Model 2000SM2
Sovereign America Surgical Mask, Model 2000SM3
Common Name:Surgical Mask
Regulation Number:21 CFR 878.4040
Classification:Class II
Product Code:FXX

Predicate Devices: 4.

510(k) Number:K160269
Trade Name:San-M Package Co., Ltd. Level 2 and 3 Surgical Face Mask
(Ear loops and Tie-on)
Common Name:Surgical Mask

5

Regulation Number: 21 CFR 878.4040 Regulatory Class: Class II Product Code: FXX

5. Device Description:

The Sovereign America Surgical Mask, Models 2000SM2 and 2000SM3, is a single use, three-layer, flat-pleated surgical mask with ear loops and a nose piece. Each 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. Each 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. Each 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. Each is provided non-sterile and intended to be a single use, disposable device.

Intended Use: 6.

Each Sovereign America Surgical Mask is intended for use by adult patients and healthcare personnel to protect against the transfer of microorganisms, bodily fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. Each proposed device is a single use, disposable device, provided non-sterile.

Comparison to Predicate Devices: 7.

Table 1: Summary of Technological Characteristics with the Predicate Device

FeatureLevel 2Level 3Level 2Level 3Comparison
ManufacturerHomtex, Inc.-San-M Package Co., Ltd.--
510(k) numberK211066-K160269--
Device Common
NameSurgical Mask-Surgical Mask-Same
ClassificationClass II Device, FXX
(21 CFR878.4040)-Class II Device, FXX
(21 CFR878.4040)-Same
Intend useThe Sovereign American
Surgical Mask is intended for
use by adult patients and
healthcare personnel to protect
against the transfer of
microorganisms, bodily fluids
and particulate material. These
face masks are intended for use
in infection control practices to
reduce the potential exposure
to blood and body fluids. This is
a single use, disposable device,
provided non-sterile.The surgical face masks are
intended to be worn toprotect
both the patient and healthcare
personnel from transfer of
microorganisms, body fluids, and
particulate material. These face
masks are intended for use in
infection control practices to
reduce the potential exposure to
blood and body fluids. This is a
single-use, disposable device,
provided non-sterile.Similar
Model StyleFlat-pleated; ear loopsFlat-pleated; ear loopsSame
MaterialOuter layerSpunbond nonwoven
polypropylenePolypropyleneSimilar
Middle layerMelt-blown nonwoven
polypropyleneTwo layers - Spunbond
polypropylene and Meltblown
polypropyleneSimilar
Inner layerSpunbond nonwoven
polypropylenePolypropyleneSimilar
Nose PiecePolypropylene coated aluminum
wirePolyethylene coated steel wireSimilar
Ear loopPolyester spandex elasticPolyester, polyurethane with
polyester spunbond side tapesDifferent
ColorBlueWhite or blueSimilar
Dimension (Width)175 mm175 ± 5 mm180 ± 5 mmSimilar
Dimension (Length)95 mm90 ± 3 mm90 ± 3 mmSimilar
OTC useYesYesSame
SterilityNon-SterileNon-SterileSame
UseSingle Use, DisposableSingle Use, DisposableSame
LatexNot Made with Natural Rubber
LatexUnknownUnknown
Performance (ASTM F2100)
ASTM F2100 LevelLevel 2Level 3Level 2Level 3Same
Fluid Resistance
(ASTM F1862)32/32 passed
at 120 mm Hg31/32 passed at
160 mm HgPassed at 120
mm HgPassed at 160
mm HgSame
Bacterial Filtration
Efficiency
(ASTM F2101)Passed at
99.1 - 99.9%Passed at
99.1 - 99.9%Passed at >98%Passed at >99%Simliar
Particulate Filtration
Efficiency
(ASTM F2299)Passed at
99.55 - 99.91%Passed at
99.55 - 99.91%Passed at 99.6%Passed at 99.7%Similar
Differential Pressure
(EN 14683/MIL-M-
36954C)Passed at
2.5 - 3.3 mm
H2O/cm²Passed at
2.5 - 3.3 mm
H2O/cm²Passed at 1.6
mm H2O/cm²Passed at 2.5
mm H2O/cm²Similar
Flammability
(16 CFR 1610)Passed as Class 1Passed as Class 1Same
Biocompatibility
Cytotoxicity
(MEM Elution)
ISO 10993-5:2009Non-CytotoxicNon-CytotoxicSame
Intracutaneous
Reactivity
ISO 10993-10:2010Non-IrritatingNon-IrritatingSame
Kligman
Maximization
Sensitization
ISO 10993-10:2010Non-SensitizingNon-SensitizingSame

6

7

Non-Clinical Testing: 8.

Sovereign America Surgical Mask, Models 2000SM2 and 2000SM3, 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, Models 2000SM2 and 2000SM3, passed all acceptance criteria in the consensus standards as set forth in Tables 2, 3, and 4 below.

Table 2: Performance Testing - Sovereign America Surgical Mask Model 2000SM2
Testing StandardsAcceptance Criteria
ASTM F2100 Level 2Sovereign America
Surgical Mask
Model 2000SM2Predicate
Device
(K160269)Result
Fluid Resistance
(ASTM F1862)29/32 pass at 120
mm Hg32/32 pass at 120
mm HgPass at 120
mm HgMeets or
exceeds
acceptance
criteria
Bacterial Filtration
Efficiency
(ASTM F2101)≥ 98%99.1 - 99.9%≥ 98%Meets or
exceeds
acceptance
criteria

8

| Particulate Filtration
Efficiency
(ASTM F2299) | ≥ 98% | 99.55 - 99.91 % | 99.6% | Meets or
exceeds
acceptance
criteria |
|------------------------------------------------------|------------------|-------------------------|-------------------|-----------------------------------------------|
| Differential Pressure
(EN 14683/
MIL-M-36954C) |