Heartland Health Surgical Mask

• K Number: K212366
• Device Name: Heartland Health Surgical Mask
• Manufacturer: Heartland Health Products
• Date Cleared: 2022-02-19 ( 204 days)
• Product Code: FXX
• Regulation Number: 878.4040

Intended Use

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.

Predicate Devices

K131879

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
A therapeutic device is used to treat or cure a disease or condition. This device is intended to protect against the transfer of microorganisms, not to treat or cure a condition.

Diagnostic

No
The device is a surgical mask intended for protection against microorganisms and body fluids, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, three-layer face mask with hardware components like elastic headbands and a nose wire. The performance studies also focus on physical properties and material testing, not software validation.

IVD (In Vitro Diagnostic)

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, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
• Device Description: The description details the physical construction of a mask, not a device designed to analyze biological samples.
• Performance Studies and Key Metrics: The performance studies focus on the physical properties of the mask (filtration efficiency, fluid resistance, breathability, flammability, biocompatibility), which are relevant to its function as a barrier, not its ability to diagnose a condition.
• Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This surgical mask does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FXX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nose and mouth

Indicated Patient Age Range

Adults

Intended User / Care Setting

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

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 was conducted in accordance with FDA's "Guidance for Industry and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission," issued March 5, 2004.
Test Methodology: ASTM F1862:2017- Fluid Resistance Performance
Purpose: 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.
Acceptance Criteria: Class 3 - pass at 160mmHg Class 2 - pass at 120mmHg Class 1- pass at 80mmHg
Results: Pass

Test Methodology: ASTM F2299:2017 - Particulate Filtration Efficiency
Purpose: 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
Acceptance Criteria: >98%
Results: Pass

Test Methodology: ASTM F2101:2019 - Bacterial Filtration Efficiency
Purpose: 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.
Acceptance Criteria: >98%
Results: Pass

Test Methodology: EN 14683:2019 - Differential Pressure
Purpose: Evaluate the resistance to air flow and breathability of a medical face mask by measuring differential pressure through the materials of a mask
Acceptance Criteria:

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

1

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,

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 Dr
Cincinnati, OH 45246
Contact Person:	Frank Fischer, Chief Operating Officer
Phone:	513-870-1611
Email:	[e-mail]
Correspondent:	Doug Keefe, Quality/Regulatory Manager
Correspondent Phone:	513-870-1611
Correspondent Email:	[e-mail]

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:

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.

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| Table 1. Predicate
Comparison

Description	Subject Device	Predicate (K131879)	Comparison
Indication for Use	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.	The Kimberly-Clark
KC300 Face 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.	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 new
issues of safety or
efficacy
Materials
Outer facing layer	Polypropylene
spunbond	Polyethylene/polyester
with pink and blue ink	Similar, both met
performance and
biocompatibility
requirements
Middle layer	Polypropylene	Polypropylene
spunbond,
polypropylene
meltblown	Same
Inner facing layer	Polypropylene
spunbond	Polyethylene/polyester	Similar, both met
performance and
biocompatibility
requirements
Table 1. Predicate
Comparison
Description	Subject Device	Predicate (K131879)	Comparison
Chin elastic	Lycra	N/A	Different. both
met performance and
biocompatibility
requirements
Nose piece	Polyethylene and soft
annealed carbon steel	Unknown	Similar. both met
performance and
biocompatibility
requirements
Headband materials	Spunbond
polypropylene, spandex
with blue ink	Polyester/Lycra knitted	Similar, both met
performance and
biocompatibility
requirements
Colorants	Aquaking Pro Cyan
(headband)	Markem Ink
(facepiece)	Different, both met
biocompatibility
requirements
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 new
issues of safety or
efficacy
Dimension (width)	105 ± 6 mm (3.7" ±
0.24") (small and large)	4" ± 0.75"	Similar, but no new
issues of safety or
efficacy
Color	white (facepiece)
blue (headband)	Pink and blue
(facepiece)	Different, both met
biocompatibility
requirements
Testing
NIOSH Certification
number	N/A	N/A	Same
ASTM F2100-19
Level	Level 3	Level 3	Same
Biocompatibility (ISO

10993.                       | Non-cytotoxic, Non-
       

sensitizing, Non-
irritating | Non-cytotoxic, Non-
sensitizing, Non-
irritating | Same |
| Test Methodology | Purpose | Acceptance Criteria | Results |
| 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 |