The surgical mask is intended to be worn to protect 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.

Device Description

The surgical mask is a three-layer, flat pleated facepiece composed of a spunbond outer layer, filter layer, and spunbond (skin-contacting) inner layer. The mask is held in place with an elastic headband, and the position of the mask on the face is maintained with a nose wire and elastic beneath the chin. It is supplied non-sterile and is a single-use disposable.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided text.

This document describes the validation of a Surgical Mask, not an AI/software device. Therefore, many of the typical acceptance criteria and study components for AI-driven medical devices (like MRMC studies, ground truth establishment by experts, training/test set provenance, etc.) are not applicable here. The study focuses on physical and biological performance characteristics of the mask according to recognized standards.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established ASTM and ISO standards for surgical masks.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
ASTM F1862:2017 - Fluid Resistance Performance	Evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood.	Class 3 - pass at 160mmHg Class 2 - pass at 120mmHg Class 1- pass at 80mmHg	Pass
ASTM F2299:2017 - Particulate Filtration Efficiency	Evaluate filtration efficiency by comparing the particle count in the feed stream (upstream) to that in the filtrate (downstream) for the materials used in medical face masks.	>98%	Pass
ASTM F2101:2019 - Bacterial Filtration Efficiency	Evaluate the effectiveness of medical face mask materials in preventing the passage of aerosolized bacteria, expressed in the percentage of a known quantity that does not pass the medical face mask material at a given aerosol flow rate.	>98%	Pass
EN 14683:2019 - Differential Pressure	Evaluate the resistance to air flow and breathability of a medical face mask by measuring differential pressure through the materials of a mask.	< 6.0mmH2O/cm²	Pass
16 CFR 1610 - Flammability	Evaluate the resistance of a mask to ignition when exposed to a flame.	Class 1	Pass
ISO 10993-5:2009, Cytotoxicity	Evaluate the potential of a medical device to cause cytotoxic reactions in mammalian cell culture.	Under the conditions of the study, the predicate device extract was determined to be non-cytotoxic	Pass
ISO 10993-10: 2021, Irritation	Evaluate the potential of a medical device to cause skin irritation.	Under the conditions of the study, the predicate device non-polar and polar extracts were determined to be non- irritating.	Pass

Study Details (Applicable vs. Not Applicable for a Surgical Mask K-Submission)

Given that this is a 510(k) submission for a surgical mask, the validation is focused on objective, measurable physical and material properties, rather than diagnostic performance in a clinical setting with human readers or AI algorithms.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact sample sizes (number of masks, or number of tests conducted per mask) for each test. These are typically defined by the specific ASTM/ISO standards referenced.
Data Provenance: Not explicitly stated regarding country of origin. The studies are non-clinical testing conducted in accordance with FDA's "Guidance for Industry and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission." This implies laboratory testing of the product itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. For a surgical mask, "ground truth" is established by the results of standardized physical, chemical, and biological tests, not by human expert interpretation of images or clinical data. No human experts are mentioned as establishing "ground truth" for these performance tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. Adjudication methods are relevant for subjective interpretations (e.g., radiological reads, pathology slides). The tests for a surgical mask are objective and quantitative.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is a physical device, not an AI or software product. No human readers or AI assistance are involved in its primary function or performance evaluation.

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

Not Applicable. This is a physical device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Standardized Test Results: The "ground truth" for this device is the objective performance measured against predefined thresholds in recognized international standards (ASTM, ISO, EN, CFR) for fluid resistance, filtration efficiency, flammability, and biocompatibility.

8. The sample size for the training set:

Not Applicable. This device does not involve machine learning; therefore, there is no "training set."

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set for an AI model, this is irrelevant.

Summary

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February 19, 2022

Heartland Health Products Frank Fischer Chief Operating Officer 5389 East Provident Dr Cincinnati, Ohio 45246

Re: K212366

Trade/Device Name: Heartland Health Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 25, 2022 Received: January 25, 2022

Dear Frank Fischer:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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

Sincerely,

Clarence W. Murray, III, PhD 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

Device Name Heartland Health Surgical Mask

Indications for Use (Describe)

The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face 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 nonsterile.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date of Summary Prepared: 01/21/2022

510(k) Number:	K212366
Submitted by:
Company Name:	Heartland Health Products
Company Address:	5389 East Provident DrCincinnati, OH 45246
Contact Person:	Frank Fischer, Chief Operating Officer
Phone:	513-870-1611
Email:	ffischer@heartlandhealthproducts.com
Correspondent:	Doug Keefe, Quality/Regulatory Manager
Correspondent Phone:	513-870-1611
Correspondent Email:	dougkeefe@heartlandhealthproducts.com

Regulatory Information:

Trade Name:	Heartland Health Surgical Mask
Common/Usual Name:	Surgical mask
Product Code:	FXX
Regulation Number:	21 CFR 878.4040
Device Class:	Class II
Reviewing Panel:	General Hospital
Basis for Submission:	New device abbreviated 510(k)

Predicate Device:

510(k) Number:	K131879
510(k) Holder:	Kimberly-Clark*
Device Name:	Surgical mask

Indications for Use:

Device Description:

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Table 1. PredicateComparisonDescription	Subject Device	Predicate (K131879)	Comparison
Indication for Use	The surgical mask isintended to be worn toprotect both the patientand healthcarepersonnel from transferof microorganisms,body fluids, andparticulate material.These face masks areintended for use ininfection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single-use,disposable device,provided non-sterile.	The Kimberly-ClarkKC300 Face Mask isintended to be worn toprotect both the patientand healthcarepersonnel from transferof microorganisms,body fluids, andparticulate material.These face masks areintended for use ininfection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single-use,disposable device,provided non-sterile.	Same
Environment of Use	OTC	OTC	Same
Sterility	Non-sterile	Non-sterile	Same
Use	Single-use, disposable	Single-use, disposable	Same
Anatomical site	Nose and mouth	Nose and mouth	Same
Target Population	Adults	Adults	Same
Design Features
Mask style	Flat-pleated	Flat-pleated	Same
Design	Headband	Ear loops, tie strings	Different, but no newissues of safety orefficacy
Materials
Outer facing layer	Polypropylenespunbond	Polyethylene/polyesterwith pink and blue ink	Similar, both metperformance andbiocompatibilityrequirements
Middle layer	Polypropylene	Polypropylenespunbond,polypropylenemeltblown	Same
Inner facing layer	Polypropylenespunbond	Polyethylene/polyester	Similar, both metperformance andbiocompatibilityrequirements
Table 1. PredicateComparisonDescription	Subject Device	Predicate (K131879)	Comparison
Chin elastic	Lycra	N/A	Different. bothmet performance andbiocompatibilityrequirements
Nose piece	Polyethylene and softannealed carbon steel	Unknown	Similar. both metperformance andbiocompatibilityrequirements
Headband materials	Spunbondpolypropylene, spandexwith blue ink	Polyester/Lycra knitted	Similar, both metperformance andbiocompatibilityrequirements
Colorants	Aquaking Pro Cyan(headband)	Markem Ink(facepiece)	Different, both metbiocompatibilityrequirements
Specifications and Dimensions
Layers	Three	Multiple	Similar
Dimension (length)	241 ± 7mm (9.5" ± .28")(small)279 ± 7mm (11" ± .28")(large)	6.5" ± 0.75"	Different, but no newissues of safety orefficacy
Dimension (width)	105 ± 6 mm (3.7" ±0.24") (small and large)	4" ± 0.75"	Similar, but no newissues of safety orefficacy
Color	white (facepiece)blue (headband)	Pink and blue(facepiece)	Different, both metbiocompatibilityrequirements
Testing
NIOSH Certificationnumber	N/A	N/A	Same
ASTM F2100-19Level	Level 3	Level 3	Same
Biocompatibility (ISO10993)	Non-cytotoxic, Non-sensitizing, Non-irritating	Non-cytotoxic, Non-sensitizing, Non-irritating	Same
Test Methodology	Purpose	Acceptance Criteria	Results
ASTM F1862:2017-Fluid ResistancePerformance	Evaluate the resistance of medicalface masks to penetration by theimpact of a small volume (~2 mL) ofa high-velocity stream of syntheticblood.	Class 3 - pass at160mmHgClass 2 - pass at120mmHgClass 1- pass at 80mmHg	Pass
ASTM F2299:2017 -Particulate FiltrationEfficiency	Evaluate filtration efficiency bycomparing the particle count in thefeed stream (upstream) to that inthe filtrate (downstream) for thematerials used in medical facemasks	>98%	Pass
ASTM F2101:2019 -Bacterial FiltrationEfficiency	Evaluate the effectiveness ofmedical face mask materials inpreventing the passage ofaerosolized bacteria, expressed inthe percentage of a known quantitythat does not pass the medical facemask material at a given aerosolflow rate.	>98%	Pass
EN 14683:2019 -DifferentialPressure	Evaluate the resistance to air flowand breathability of a medical facemask by measuring differentialpressure through the materials of amask	< 6.0mmH2O/cm²	Pass
16 CFR 1610 -Flammability	Evaluate the resistance of a maskto ignition when exposed to a flame	Class 1	Pass
ISO 10993-5:2009,Cytotoxicity	Evaluate the potential of amedical device to causecytotoxic reactions inmammalian cell culture	Under the conditions of thestudy, the predicate deviceextract was determined tobe non-cytotoxic	Pass
ISO 10993-10:2021, Irritation	Evaluate the potential of amedical device to cause skinirritation	Under the conditions of thestudy, the predicate devicenon-polar and polarextracts were determinedto be non- irritating.	Pass

Summary of Comparison and Technological Characteristics

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Non-clinical testing was conducted in accordance with FDA's "Guidance for Industry and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission," issued March 5, 2004. A summary of performance testing, including references to recognized standards, is provided below in Table 2. Table 2: Summary of Non-Clinical Testing

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Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the proposed device in 510(K) submission K212366, Heartland Health Surgical Mask is as safe, as effective and performs as well as or better than the legally marketed predicate device (K131879), Kimberly-Clark KC300 Face Mask.

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.