← Product Code [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX) · K210101 # American-Made Surgical Mask (K210101) _Armbrust, Inc. · FXX · Jan 26, 2022 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K210101 ## Device Facts - **Applicant:** Armbrust, Inc. - **Product Code:** [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX.md) - **Decision Date:** Jan 26, 2022 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use The Armbrust American made Surgical Mask, model AA-US-SURGICAL-01 is intended to be worn by adults to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material within a professional healthcare environment. These surgical 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(s), provided non-sterile. For adult use. ## Device Story Adult-sized surgical mask; provides physical barrier to fluids and particulates; worn by healthcare personnel and patients. Composed of three layers: outer fluid-resistant polypropylene spunbond; middle electrostatically charged polypropylene meltblown for filtration; inner fluid-resistant polypropylene spunbond. Features flat pleats and malleable nose wire for fit; secured via elastic earloops. Single-use, disposable, non-sterile. Used in professional healthcare settings for infection control. Provides ASTM F2100-19 Level 3 barrier protection. ## Clinical Evidence No clinical data. Bench testing only. Performance verified per ASTM F2100-19: Fluid resistance (ASTM F1862) passed at 160 mmHg; Particulate Filtration Efficiency (ASTM F2299) 99.48%; Bacterial Filtration Efficiency (ASTM F2101) 99.4%; Differential Pressure 4.7 mm H2O; Flammability Class 1. Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed non-cytotoxic, non-irritating, and non-sensitizing. ## Technological Characteristics Three-layer construction: polypropylene spunbond (outer/inner), polypropylene meltblown (middle). Malleable nose wire (galvanized iron coated in polypropylene). Elastic earloops (polyester/spandex). Dimensions: 175mm x 95mm. ASTM F2100-19 Level 3 compliant. Non-sterile. Single-use. No software or energy source. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Kimberly-Clark KC200 Face Mask(s), Kimberly-Clark KC300 Face Mask(s) ([K111402](/device/K111402.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. January 26, 2022 Armbrust Inc. Landon Morales President Armbrust Inc, 3813 Helios Way Building B, Suite 290, Pflugerville, TX 78660 USA. 3813 Helios Way Building B, Suite 290 Pflugerville, Texas 78660 Re: K210101 Trade/Device Name: Armbrust American Made Surgical Mask, model AA-US-SURGICAL-01 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 9, 2021 Received: December 21, 2021 Dear Landon Morales: 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 {1}------------------------------------------------ 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 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, For 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210101 ### Device Name Armbrust American Made Surgical Mask, model AA-US-SURGICAL-01 Indications for Use (Describe) The Armbrust American made Surgical Mask, model AA-US-SURGICAL-01 is intended to be worn by adults to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material within a professional healthcare environment. These surgical 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(s), provided non-sterile. For adult use. | 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 G) | | | Prescription Use (Part 21 CFR 801 Subpart D) |X| 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}------------------------------------------------ 510(k) Summary - K210101 This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92. | I. Sponsor | Armbrust Inc.
3813 Helios Way
Building B, Suite 290
Pflugerville, TX 7866 | |----------------------------|----------------------------------------------------------------------------------------------------| | II. 510(k) Contact Person: | Landon Morales
President, Armbrust Inc.
Email: landon@armbrustusa.com
Phone: 561-809-1586 | | Date : January 24, 2022 | | ### III. Device | Name of the Device: | Armbrust American Made Surgical Mask, model AA-US-SURGICAL-01 | |--------------------------|-------------------------------------------------------------------------| | Common Name: | Mask, Surgical | | Classification Name: | Surgical Apparel (21 CFR §878.4040) | | Device Product Code: | FXX | | Regulatory Class: | Class II | | IV. Predicate Device | | | Predicate device 510(k): | K111402 | | Predicate device name: | Kimberly-Clark KC200 Face Mask(s), Kimberly-Clark KC300 Face
Mask(s) | This predicate device has not been subject to a design-related recall. ### V. Device Description: The USA-Made Surgical Mask, model number AA-US-SURGICAL-01, is an adult sized surgical mask with earloops that is designed to cover the user's nose and mouth and provides a physical barrier to fluids and particulate materials. The USA-Made Surgical Mask is composed of threelayers and features flat pleats. The three layers are comprised of a blue in color fluid resistant polypropylene spunbond (outer layer), electrostatically charged polypropylene meltblown layer for filtration (middle layer), and an additional fluid resistant polypropylene spunbond (inner {4}------------------------------------------------ layer). A malleable nose wire is used in the top of the mask to achieve a proper fit for individuals. The USA-Made Surgical Mask is a single use, disposable device that is provided non-sterile. The surgical mask conforms to ASTM F2100-19, providing a level 3 barrier. #### VI. Indications for Use: The USA-Made Surgical Mask is intended to be worn by adults to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material within a professional healthcare environment. These surgical 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(s), provided non-sterile. For adult use. #### Comparison of Technological Characteristics with the Predicate Device(s) VII. Table 1 below is a high-level comparison between the subject device. Armbrust Inc. USA-Made Surgical Mask AA-US-SURGICAL-01 (K210101) and the predicate device, Kimberly-Clark KC200 Face Mask(s), Kimberly-Clark KC300 Face Mask(s) (K111402). | Feature | Subject Device
USA-Made Surgical
Mask, Model AA-US-
SURGICAL-01 | Predicate Device
Kimberly-Clark, Model
KC200 Face Mask(s),
KC300 Face Mask(s) | Comparison
of Devices | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------| | 510(k) Number | K210101 | K111402 | N/A | | Manufacturer | Armbrust Inc. | Kimberly-Clark | N/A | | Indications for Use | The USA-Made Surgical
Mask is intended to be
worn by adults to protect
both the patient and
healthcare personnel
from transfer of
microorganisms, body
fluids and particulate
material within a
professional healthcare
environment. These
surgical 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(s),
provided non-sterile. For
adult use. | The Kimberly-Clark,
KC200 Face Mask(s)
and KC300 Face
Mask(s) are 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 of
the wearer to blood and
body fluids. The
Kimberly-Clark, KC300
face mask(s) is a single
use, disposable
device(s), provided non-
sterile. | Same | | Feature | Subject Device
USA-Made Surgical
Mask, Model AA-US-
SURGICAL-01 | Predicate Device
Kimberly-Clark, Model
KC200 Face Mask(s),
KC300 Face Mask(s) | Comparison
of Devices | | Design Features | | | | | Color, outer fabric | Blue | Orange | Different | | Style | Flat, pleated | Flat, pleated | Same | | Layers | 3 | 4 | Different | | Physical state | Single use only | Single use only | Same | | Sterility | Non-sterile | Non-sterile | Same | | Retention features | Elastic ear loops | Elastic ear loops or ties | Different | | Materials critical to
functionality | Spunbond
polypropylene,
Meltblown
polypropylene, spunbond
polypropylene,
Polyester/spandex
elastic (earloop),
Galvanized iron coated
in polypropylene | Polypropylene
Spunbond,
Polypropylene
spunbond (4th layer
addition), Polypropylene
Meltblown, Polyester
cellulose, Polyester
Spunlace, Polyester/
Lycra Knit (earloop),
Polyester spunbond
(ties), malleable
nosewire | Same | | Dimensions | | | | | Width | 175mm ±7mm | 6.5" ±0.75" | Different | | Height | 95mm ±7mm | 4" ±0.75" | Different | | Performance Specification | | | | | ASTM F2100 Level | Level 3 | Level 3 | Same | | Fluid Resistance
(ASTM F1862) | Passed at 160 mmHg | Passed at 160 mmHg | Same | | Particulate Filtration
Efficiency (PFE) | Passed at >98% | Passed at >98% | Same | | Bacterial Filtration
Efficiency (BFE) | Passed at >98% | Passed at >98% | Same | | Differential Pressure | Passed at <5mmH2O | Passed at <5mmH2O | Same | | Flammability (16
CFR 1610) | Class 1 | Class 1 | Same | | Biocompatibility | | | | | Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Same | | Irritation | Non-irritating | Non-irritating | Same | | Sensitization | Non-sensitizing | Non-sensitizing | Same | ## Table 1 - Summary of Technological Characteristics with the Predicate Device {5}------------------------------------------------ {6}------------------------------------------------ ## VIII Non-Clinical (Performance) Testing For USA-Made Surgical Mask, Model AA-US-SURGICAL-01, the following table summarizes the performance testing conducted per ASTM F2100 standard: | Item Tested | Test Method | Purpose | Acceptance
Criteria | Results | |-------------------|---------------------------------|----------------------------------------|------------------------|-------------------------------| | AA-US-SURGICAL-01 | ASTM F1862 | Fluid Resistance to
Synthetic Blood | 160 mmHg | No penetration
at 160 mmHg | | AA-US-SURGICAL-01 | ASTM F2299 | Particulate Filtration
Efficiency | >98% | Average
99.48% | | AA-US-SURGICAL-01 | ASTM F2101 | Bacterial Filtration
Efficiency | >98% | Average
99.4% | | AA-US-SURGICAL-01 | ASTM F2100 | Differential Pressure | <5mmH2O | Average
4.7mm H2O | | AA-US-SURGICAL-01 | CPSC CS-191-53
(16 CFR 1610) | Flammability | Class 1 | IBE, Class 1 | Table 2 - Summary of Non-Clinical (Performance) Testing IBE= Ignited but extinguished ## IX. Biocompatibility Testing: The biocompatibility evaluation for the USA-Made Surgical Mask, Model AA-US-SURGICAL-01 device was conducted in accordance with the FDA's Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: | Item Tested | Test Description | Test Methodology | Acceptance
Criteria | Results | |-------------------|------------------------------|------------------|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | AA-US-SURGICAL-01 | Cytotoxicity | ISO 10993-5 | No signs of
Toxicity | Grade 0, Non-Cytotoxic.
Under the conditions of the
study, the subject device
extract was determined to be
non-cytotoxic. PASS. | | AA-US-SURGICAL-01 | Intracutaneous
Irritation | ISO 10993-10 | Negligible
signs of
irritation | Non-irritant.
Under the conditions of the
study, the subject device non-polar
and polar extracts were
determined to be | {7}------------------------------------------------ | | | | | non- irritating.
PASS. | |-----------------------|-------------------------------|--------------|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AA-US-SU
RGICAL-01 | Maximization
Sensitization | ISO 10993-10 | Negligible
signs of
sensitization | Non-sensitizer.
Under the
conditions of the
study, the
subject device
non- polar and
polar extracts
were determined
to be non-
sensitizing.
PASS. | #### Summary of Clinical Performance Test X. No clinical study is included in this submission. ### XI. Conclusions for Substantial Equivalence: The Armbrust Inc USA-Made Surgical Mask, Model: AA-US-SURGICAL-01 and predicate devices, Kimberly-Clark KC200 Face Mask(s), Kimberly-Clark KC300 Face Mask(s) (K111402) have the same intended use and similar technological characteristics. The conclusions drawn from the non-clinical tests demonstrates that the subject device Armbrust Inc USA-Made Surgical Mask, Model: AA-US-SURGICAL-01 is as safe and as effective as the legally marketed predicate device. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K210101](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K210101) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com