Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance testing focus on the physical properties and filtration capabilities of a standard procedure mask. There is no mention of AI or ML in the intended use, device description, or testing summaries.

Therapeutic

No
The device is described as a mask intended for infection control to protect from transfer of microorganisms, not for treating a disease or condition.

Diagnostic

No

The device is a procedure mask intended to protect against transfer of microorganisms and fluids, and its performance studies focus on filtration efficiency and biocompatibility, not on detecting, diagnosing, or monitoring medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical mask made of polypropylene layers, secured with earloops. It is a tangible, disposable hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the mask is for protecting both the patient and healthcare personnel from 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 the mask (layers, earloops, materials). There is no mention of reagents, test strips, or any components used to analyze biological samples.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This mask does not perform any such analysis.
Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, fluid resistance, breathability, flammability) and biocompatibility, which are relevant to a barrier device, not a diagnostic one.

Therefore, based on the provided information, the Honeywell Procedure Mask is a medical device intended for personal protection and infection control, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Honeywell Procedure 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 potential exposure to blood and body fluids. This is a single use, disposable device, provided nonsterile.

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

FXX

Device Description

The Honeywell Procedure Mask is composed of three layers that are a flat, pleated style mask with earloops to secure it over the users' mouth and face. The inner and outer layers are manufactured from spun-bond polypropylene. The middle layer is made of melt-blown polypropylene. The mask is a single use, disposable device, provided nonsterile and is not made from natural rubber latex.

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

Not Found

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)

Performance Testing:
Mask performance was tested to ASTM's F2100 standard. Each type of performance testing used 32 samples in each of 3 different, non-consecutive lots.
Tests included:
ASTM F1862 for Fluid Resistance/Synthetic Blood Penetration, passed at 120 mmHg.
ASTM F2299 for Particulate Filtration Efficiency, passed at >=99.45% @ 0.1 micron.
ASTM F2101 for Bacterial Filtration Efficiency, passed at >=98.2% @ 3.0 micron.
EN 14683 Annex C for Differential Pressure "Breathability", passed at =99.45% @ 0.1 micron
Bacterial Filtration Efficiency: >=98.2% @ 3.0 micron
Differential Pressure "Breathability":

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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

July 28, 2021

Honeywell Safety Products Ivy Grieco Senior Advanced Quality Engineer 10 Thurber Boulevard Smithfield, Rhode Island 02917

Re: K211497

Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 11, 2021 Received: May 14, 2021

Dear Ivy Grieco:

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); 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

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Indications for Use

510(k) Number (if known)

K211497

Device Name Honeywell Procedure Mask

Indications for Use (Describe)

The Honeywell Procedure 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 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)

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

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510(k) Summary (K211497)

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

I. SPONSOR

Honeywell Safety & Productivity Solutions 10 Thurber Blvd. Smithfield, RI 02917 USA

II. CONTACT PERSON

Ivy Grieco Title: Sr. Adv. Quality Engineer Phone: 401-864-0496 Email: Ivy.Grieco@Honeywell.com Date Prepared: July 21, 2021

III. DEVICE

Name of Device: Honeywell Procedure Mask Common or Usual Name: Procedure Mask Classification Name: Surgical Apparel (21 CFR §878.4040) Requlatory Class: II Product Code: FXX

IV. PREDICATE DEVICE

Manufacturer: Changzhou Combat Protective Equipment Co., Ltd. Device: Nordiwell Medical Face Mask 510(k) Number: K210445 This predicate has not been subject to a design-related recall.

V. DEVICE DESCRIPTION

The Honeywell Procedure Mask is composed of three layers that are a flat, pleated style mask with earloops to secure it over the users' mouth and face. The inner and outer layers are manufactured from spun-bond polypropylene. The middle layer is made of melt-blown polypropylene. The mask is a single use, disposable device, provided nonsterile and is not made from natural rubber latex.

VI. INDICATIONS FOR USE

The Honeywell Procedure 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 potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

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VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Honeywell Procedure Mask is compared with the predicate device Nordiwell Face Mask (K210445)). The results are shown below in the Technological Characteristics Comparison Table:

| Item | Subject Device
Honeywell Procedure Mask | Predicate Device
Nordiwell Medical Face Mask | Comparison |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | K211497 | K210445 | |
| Intended Use
Statement | The Honeywell Procedure 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
potential exposure to blood and body
fluids. This is a single use, disposable
device, provided non-sterile. | The Nordiwell Medical Face Mask is
intended to be worn to protect both
patient and healthcare personnel from
transfer of microorganisms, body
fluids, and particulate matters.