← Product Code [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX) · K222749 # High Fluid-Resistant Surgical and Procedure Mask (K222749) _America’S Supply Chains · FXX · Nov 14, 2022 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K222749 ## Device Facts - **Applicant:** America’S Supply Chains - **Product Code:** [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX.md) - **Decision Date:** Nov 14, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** 3rd-Party Reviewed ## Intended Use The High Fluid-Resistant Surgical and 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. The face mask is a single use, disposable device, provided non-sterile. ## Device Story Four-layer, flat-pleated, single-use, non-sterile surgical mask; consists of polypropylene spunbond outer/insertion layers, polypropylene melt-blown filter web, and polypropylene thermal-bonded inner layer; features spandex ear loops and polyethylene-coated steel nose piece. Used in clinical settings for infection control; worn by healthcare personnel and patients to provide barrier protection against fluids and particulates. Device is passive; no electronic or software components. ## Clinical Evidence Bench testing only. No clinical data required. Performance testing included fluid resistance (ASTM F1862), particulate filtration efficiency (ASTM F2299), bacterial filtration efficiency (ASTM F2101), differential pressure, and flammability (16 CFR 1610). Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993-1:2018. All tests passed. ## Technological Characteristics 4-ply flat-pleated mask. Materials: Polypropylene spunbond (outer/insertion), polypropylene melt-blown (filter), polypropylene thermal-bonded (inner). Nose piece: Polyethylene-coated steel wire. Ear loops: Spandex elastic. ASTM F2100 Level 3 compliant. Non-sterile, single-use. Passive device; no energy source, connectivity, or software. ## 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 - 3M High Fluid-Resistant Procedure Mask Model Number 1840 ([K191355](/device/K191355.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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. November 14, 2022 America's Supply Chains % Prithul Bom, MBA, MS, RAC (US, EU), CSQE Accredited Person, Reviewer Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k Saint Paul, Minnesota 55114 Re: K222749 Trade/Device Name: High Fluid-Resistant Surgical and Procedure Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 31, 2022 Received: November 1, 2022 Dear Ms. Bom: 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 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, Brent Showalter -S Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K222749 Device Name High Fluid-Resistant Surgical and Procedure Mask #### Indications for Use (Describe) The High Fluid-Resistant Surgical and 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 intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is a single use, disposable device, provided non-sterile. | 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)
| 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}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the logo for "America's Supply Chains." The logo features the text "America's" in a bold, blue font, with the "A" being significantly larger than the rest of the letters. Below "America's" is the text "Supply Chains" in a smaller, sans-serif font. Above the text is a circular emblem containing a stylized image of a building with columns, suggesting a government or institutional connection. # 510(k) Summary This summary of 510(k) is submitted in accordance with the requirements of 21 CFR 8807.92: #### I. SUBMITTER America's Supply Chains 7555 Warren Pkwy, Unit 486 Frisco, TX 75034 USA Contact Person: Paul Park Tel: (617) 800-3602 Email: americasupplychains@gmail.com Date Prepared: September 06, 2022 #### II. DEVICE Name of Device: High Fluid-Resistant Surgical and Procedure Mask Common or Usual Name: Surgical Mask Classification Name: Surgical Apparel Regulatory Class: Class II (21 CFR §878.4040) Regulation Medical Specialty: General & Plastic Surgery 510k Review Panel: General Hospital FXX Product Code: #### III. PREDICATE DEVICE Predicate Manufacturer: Predicate Trade Name: Predicate 510(k): 3M Health Care 3MTM High Fluid- Resistant Procedure Mask Model Number 1840 K191355 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for "America's Supply Chains." The logo features the word "America's" in a large, bold, dark blue font, with the word "Supply Chains" in a smaller font underneath. Above the text is an oval shape containing a small building with columns and a red roof. #### IV. DEVICE DESCRIPTION The High Fluid-Resistant Surgical and Procedure Mask is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose. This device is not made from natural rubber latex. #### V. INDICATIONS FOR USE The High Fluid-Resistant Surgical and 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. The face mask is a single use, disposable device, provided non-sterile. ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The following characteristics were compared between the subject device and the predicate device in Table 1 below. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for "America's Supply Chains". The logo features the word "America's" in a large, bold font, with the word "Supply Chains" in a smaller font underneath. Above the text is an oval shape containing a building with columns and a red roof. The building is blue and white. | Description | Subject Device
High Fluid-Resistant
Surgical and Procedure
Mask ASTM Level 3 | Predicate Device (K191355)
1840 3M™ High
Fluid-Resistant Procedure
Mask ASTM Level 3 | Comparison | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------| | Intended Use/
Indications
for Use | The High fluid-Resistant
Surgical and Procedure Mask
is intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids, and particulate
material. This face mask is
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. | 3M™ High Fluid- Resistant
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. | Same | | Materials | | | | | Outer Cover
Web | Polypropylene Spunbond,
white | Polypropylene Spunbond,
green | Similar
(Subject
device does
not have
colorant) | | Insertion | Polypropylene Spunbond,
white | Polypropylene Spunbond,
white | Same | | Filter Web
(Middle) | Polypropylene Meltblown,
white | Polypropylene Meltblown,
white | Same | | Inner Cover
Web | Polypropylene
Thermalbonded, white | Polypropylene
Thermalbonded, white | Same | | Nose Piece | Polyethylene Coated Steel
Wire | Polyethylene Coated Steel
Wire | Same | | Ear Loops | Spandex elastic cord | Spandex elastic cord | Same | | Style | Flat - Pleated | Flat - Pleated | Same | | Multiple
Layers | 4-Ply | 4-Ply | Same | | Colors | White (Outer) | Green (Outer) | Different
(Subject
device does
not have
colorant) | | Dimension
(Width) | $3.5" \pm 0.3"$ | $3.5" \pm 0.3"$ | Same | | Dimension
(Length) | $6.9" \pm 0.2"$ | $6.9" \pm 0.2"$ | Same | | OTC Use | Yes | Yes | Same | | Sterility | Non-Sterile | Non-Sterile | Same | | Use | Single Use | Single Use | Same | | ASTM F2100
Level | Level 3 | Level 3 | Same | ## [Table 1: Comparison of Predicate Devices] {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for "America's Supply Chains." The logo features the word "America's" in a large, bold font, with the word "Supply Chains" in a smaller font underneath. Above the text is a circular emblem containing a stylized image of a building with a red roof and blue columns. The overall design is clean and professional, suggesting a company involved in logistics or supply chain management. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for "America's Supply Chains." The logo features the word "America's" in a large, bold font, with the word "Supply Chains" in a smaller font underneath. Above the text is a circular emblem with a building with columns inside of it. The building is blue and white, and the roof is red. #### VII. PERFORMANCE DATA The subject device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004. A summary of the benchtop performance testing results is provided below in Table 2. | Item | Proposed Device
High Fluid-Resistant
Surgical and Procedure
Mask
ASTM Level 3 | ASTM Level 3
Mask
Standard
Acceptance
Criteria | Predicate
Device
(K191355)
3MTM High
Fluid-Resistant
Procedure
Mask
ASTM Level 3 | Result | |-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------| | ASTM
F1862/ISO
22609
Fluid
Resistance | Three non-sequential lots
of 32 (total of 96, AQL
4.0) passed at 160mmHg
Lot 1: 32 /32 pass
Lot 2: 32 /32 pass
Lot 3: 32 /32 pass | AQL 4%,
single sampling
plan, 29 out of
32 Pass at
160mmHg | 32/32 Passed at
160mm Hg | Pass | | ASTM F2299
Particulate
Filtration
Efficiency | Three non-sequential lots
of 32 (total of 96, AQL
4.0) passed at ≥98%
Lot 1: 32/32 pass
Lot 2: 32/32 pass
Lot 3: 32/32 pass | ≥ 98% | 32/32 Passed at
≥98% @ 0.1
micron | Pass | | Bacterial
Filtration
Efficiency
ASTM F2101 | Three non-sequential lots
of 32 (total of 96, AQL
4.0) passed at ≥98%
Lot 1: 32/32 pass
Lot 2: 32/32 pass
Lot 3: 32/32 pass | ≥ 98% | 31/32 Passed at
≥98% | Pass | | Differential
Pressure
ASTM | Three non-sequential lots
of 32 (total of 96) passed
at <6mmH20/cm2 | AQL 4%,
single
sampling plan, | 32/32 Passed at
<5mmH20/cm2
MIL-M36954C | Pass | #### [Table 2: Benchtop Performance Testing] {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for "America's Supply Chains." The word "America's" is in large, bold, dark blue letters, with the apostrophe represented by a stylized "S." Below "America's" is the phrase "Supply Chains" in smaller, dark blue letters. Above the text is a small, oval-shaped graphic with a red roof and blue columns, suggesting a building or institution. | F2100/EN
14683:2019 | MIL-M36954C
Lot 1: 32/32 pass
Lot 2: 32/32 pass
Lot 3: 31/32 pass | < 6.0
mmH2O/cm2 | | | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|---------------------------------------------|------| | Class 1
Flammability
16 CFR 1610 | Three non-sequential lots
of 32 (total of 96, AQL
4.0) passed Class 1
16 CFR 1610
Lot 1: Class 1, IBE
Lot 2: Class 1, IBE
Lot 3: Class 1, IBE | Class 1
< 3.5 second
burn time | 5/5 Passed $\geq$ 3
Seconds burn
time | Pass | #### Sterilization & Shelf-life Testing Not Applicable (This is a non-sterile device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.) #### Biocompatibility Testing Biocompatibility testing was performed in accordance with ISO 10993-1:2018. Specifically, the following testing endpoints were evaluated. #### [Table 3: Biocompatibility Testing] | Biocompatibility Testing Endpoints | Acceptance Criteria | Result | |------------------------------------|---------------------|--------| | Cytotoxicity - ISO 10993-5 | Non-Cytotoxic | Pass | | Skin Sensitization - ISO 10993-10 | Non- Sensitizing | Pass | | Skin Irritation - ISO 10993-10 | Non-Irritating | Pass | #### [Table 4: Summary of Non-Clinical Performance Testing] The following standards have been used to evaluate the High Fluid-Resistant Surgical and Procedure Mask: | ASTM | Standard Test Method for Evaluating the Bacterial Filtration Efficiency
(BFE) of Medical Face Mask Materials, Using a Biological Aerosol of
Staphylococcus aureus | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | F2101-19/EN
14683:2019 | | | ASTM | Standard Test Method for Resistance of Medical Face Masks to
Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume
at a Known Velocity) | | F1862/F1862M-17 | | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for "America's Supply Chains". The word "America's" is in a large, bold font, with the "A" in dark blue and the "S" in black. Below "America's" is the phrase "Supply Chains" in a smaller, sans-serif font. Above the text is a small oval containing a red roof and blue columns, resembling a government building. | AMERICA'S
SUPPLY CHAINS | Surgical Mask 510(k) Submission | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | ASTM F2299-17 | Standard Test Method for Determining the Initial Efficiency of
Materials Used in Medical Face Masks to Penetration by Particulates
Using Latex Spheres | | ASTM F2100/EN
14683:2019
ANNEX C | Standard Test Method for Differential Pressure
Standard Specification for Performance of Materials Used in Medical
Face Masks | | 16 CFR Part 1610
EN 14683:2019
ANNEX C | Standard for Flammability | | ISO 10993-5 | ISO 10993-5 Third edition 2009-06-01
Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity | | ISO 10993-10 | ISO 10993-10 Third Edition 2010-08-01
Biological evaluation of medical devices - Part 10: Tests for irritation
and skin sensitization | #### Software Verification and Validation Testing Not Applicable (Passive Device) #### Electrical safety and electromagnetic compatibility (EMC) Not Applicable (Passive Device) #### Animal Study Animal performance testing was not required to demonstrate safety and effectiveness of the device. #### Human Clinical Performance Testing Clinical testing was not required to demonstrate the safety and effectiveness of the device. #### VIII. CONCLUSIONS The conclusions drawn from the performance data demonstrate that the subject device is as safe, effective, and performs as well as or better than the legally marketed device K191355, 3M™ High Fluid- Resistant Procedure Mask manufactured by 3M Health Care. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K222749](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K222749) **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