3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask

K191355 · 3M Healthcare · FXX · Sep 11, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K191355
• Device Name: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask
• Applicant: 3M Healthcare
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Sep 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The 3M™ High Fluid-Resistant Surgical Mask and 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. The face mask is single use, disposable device, provided non-sterile.

Device Story

3M High Fluid-Resistant Surgical and Procedure Masks are four-layer, flat-pleated, single-use, non-sterile disposable face masks. They feature an outer polypropylene spunbond cover, a polypropylene spunbond insertion layer, a polypropylene melt-blown filter web, and a polypropylene thermal-bonded inner cover. Masks include a malleable nosepiece and either tie strings or ear loops for secure fit; some models include a polyethylene terephthalate face shield with an antireflection strip. Used in clinical settings for infection control, the masks act as a physical barrier to protect both patients and healthcare personnel from microorganisms, body fluids, and particulates. They are worn over the nose and mouth to reduce exposure risks during medical procedures.

Clinical Evidence

Bench testing only. No clinical data. Performance verified against ASTM F2100 Level 3 standards: Particulate Filtration Efficiency (ASTM F2299, ≥98% @ 0.1 micron), Fluid Resistance (ASTM F1862, 160mm Hg), Bacterial Filtration Efficiency (ASTM F2101, ≥98%), Differential Pressure (MIL-M36954C, <5 mmH2O/cm²), and Flammability (16 CFR 1610, Class 1). Biocompatibility testing (ISO 10993-1, -5, -10) confirmed the materials are non-cytotoxic, non-sensitizing, and non-irritating.

Technological Characteristics

Four-layer flat-pleated construction. Materials: Polypropylene spunbond (outer/insertion), polypropylene melt-blown (filter), polypropylene thermal-bonded (inner). Nosepiece: Polyethylene coated steel wire. Face shield: Polyethylene terephthalate film. Standards: ASTM F2100 (Level 3), ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610, ISO 10993-1/5/10. Non-sterile, single-use. No software or electronic components.

Indications for Use

Indicated for use by healthcare personnel and patients to reduce the transfer of microorganisms, body fluids, and particulate material, and to reduce potential exposure to blood and body fluids in infection control practices.

Regulatory Classification

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 KC300 Surgical Mask (K131879)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of an eagle, while the text on the right is written in a bold, sans-serif font. The word "FDA" is in a blue box.

September 11, 2019

3M Health Care Angie Draper Sr. Regulatory Affairs Associate 3M Center, 2510 Conway Ave., Building 275-5W-06 St. Paul, Minnesota 55144

Re: K191355

Trade/Device Name: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 19, 2019 Received: August 20, 2019

Dear Angie Draper:

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 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,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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)

#### K191355

Device Name 3MTM High Fluid-Resistant Surgical Mask 3MTM High Fluid-Resistant Procedure Mask

#### Indications for Use (Describe)

The 3M™ High Fluid-Resistant Surgical Mask and 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. The face mask is single use, disposable device, provided non-sterile.

- 1835 3MTM High Fluid-Resistant Surgical Mask
- 1835FS 3M™ High Fluid-Resistant Surgical Mask with Face Shield
- 1840 3MTM High Fluid-Resistant Procedure Mask
- 1840FS 3M™ High Fluid-Resistant Procedure Mask with Face Shield

| 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

## K191355

| | 3M™ High Fluid-Resistant Surgical Mask<br>3M™ High Fluid-Resistant Procedure Mask |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor Information: | 3M Health Care<br>2510 Conway Ave<br>3M Center, Building 275-5W-06 St.<br>Paul, MN 55144 |
| Contact Person: | Angie Draper<br>Title: Sr. Regulatory Affairs Associate<br>Phone Number: [phone]<br>Fax Number: [phone] email:<br>[e-mail] |
| Date of Summary: | April 30, 2019 |
| Common Name: | Surgical Mask |
| Classification Name: | Surgical Apparel |
| Proprietary Name: | 3M™ High Fluid-Resistant Surgical Mask<br>3M™ High Fluid-Resistant Procedure Mask |
| Review Panel: | General and Plastic Surgery |
| Product Code: | FXX |
| Device Classification: | Class II per (21 CFR §878.4040) |
| Predicate Device: | Kimberly-Clark* KC300 Surgical Mask (K131879) |
| Intended Use: | The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High<br>Fluid-Resistant Procedure Mask is intended to be worn to protect both<br>the patient and healthcare personnel from transfer of microorganisms,<br>body fluids, and particulate material. These face masks are intended for<br>use in infection control practices to reduce potential exposure to blood<br>and body fluids. The face mask is single use, disposable device,<br>provided non-sterile. |

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## Available Model Numbers

| 1835 | 3M™ High Fluid-Resistant Surgical Mask |
|--------|----------------------------------------------------------|
| 1835FS | 3M™ High Fluid-Resistant Surgical Mask with Face Shield |
| 1840 | 3M™ High Fluid-Resistant Procedure Mask |
| 1845FS | 3M™ High Fluid-Resistant Procedure Mask with Face Shield |

### Device Description:

The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask are composed of four-layers and are flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, green), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains tie strings or ear loops to secure the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask may also contain a face shield (FS) made from a polyethylene terephthalate film, which includes an antireflection strip. The face shield is adhered to the top edge of the mask to cover the upper part of the face. The mask is a single use, disposable device, provided non-sterile.

This device is not made from Natural Rubber Latex.

### Technological Characteristics:

The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask are compared with the predicate device (KC300 Surgical Mask (K131879)). The results are shown below in the Technological Characteristics Comparison Table:

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| Item(S) | Subject Device (K191355)<br>3M™ High Fluid-<br>Resistant Surgical Mask<br>ASTM Level 3 | Subject Device (K191355)<br>3M™ High Fluid-Resistant<br>Procedure Mask K191355<br>ASTM Level 3 | Predicate<br>Device(K131879)<br>KC300 Face Mask<br>ASTM Level 3 | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use/<br>Indications<br>for Use | 3M™ High Fluid- Resistant<br>Surgical Mask is intended<br>to be worn to protect both<br>the patient and healthcare<br>personnel from transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. These face masks<br>are intended for use in<br>infection control practices<br>to reduce potential exposure<br>to blood and body fluids.<br>This is a single use,<br>disposable device, provided<br>non-sterile. | 3M™ High Fluid- Resistant<br>Procedure Mask is intended to<br>be worn to protect both the<br>patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids,<br>and particulate material.<br>These face masks are intended<br>for use in infection control<br>practices to reduce potential<br>exposure to blood and body<br>fluids. This is a single use,<br>disposable device, provided<br>non-sterile. | The Kimberly-Clark<br>KC300 Surgical Mask is<br>intended to be worn to<br>protect both the patient<br>and healthcare personnel<br>from transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. These face<br>masks are intended for<br>use in infection control<br>practices to reduce the<br>potential exposure to<br>blood and body fluids.<br>This is a single use,<br>disposable device, | Same |
| | | Materials | | |
| Outer Cover<br>Web | Polypropylene Spunbond,<br>green | Polypropylene Spunbond,<br>green | Polyethylene/Polyester<br>with pink and blue ink<br>print | Different |
| Insertion | Polypropylene Spunbond,<br>white | Polypropylene Spunbond,<br>white | Unknown | Not known |
| Filter Web<br>(Middle) | Polypropylene Meltblown,<br>white | Polypropylene Meltblown,<br>white | Polypropylene Spunbond<br>and Polypropylene Melt-<br>blown | Different |
| Inner Cover<br>Web | Polypropylene Thermal-<br>bonded, white | Polypropylene Thermal-<br>bonded, white | Polyethylene/Polyester | Different |
| Nose Wire | Polyethylene Coated Steel<br>Wire | Polyethylene Coated Steel<br>Wire | Unknown | Not known |
| Edge wrap | Polypropylene Spunbond,<br>white or<br>Polyethylene<br>Terephthalate, white | Polypropylene Spunbond,<br>white or Polyethylene<br>Terephthalate, white | Polyester Spunlace or<br>Polypropylene Spunbond | Different |
| Ear Loops | Not Applicable | Spandex elastic cord<br>(polyurethane core with<br>polyethylene terephthalate<br>/nylon cover) | Polyester/Lycra Knitted | Different |
| Tie Strings | Polypropylene Spunbond,<br>White or Polyethylene<br>Terephthalate, white | Not Applicable | Polypropylene Spunbond | Different |
| | | Design Features | | |
| Colors | Green (Outer) | Green (Outer) | Multiple (Outer) | Different |
| Style | Flat - Pleated | Flat - Pleated | Flat - Pleated | Same |

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| Multiple<br>Layers | Yes | Yes | Yes | Same |
|---------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------|-----------|
| Single Use | Yes | Yes | Yes | Same |
| Sterility | | | | |
| Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Dimensions | | | | |
| Length | 6.9" ± 0.2" | 6.9" ± 0.2" | 6.5" ± 0.75" | Different |
| Width | 3.5" ± 0.3" | 3.5" ± 0.3" | 4" ± 0.75" | Different |
| Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 3 | | | | |
| Particulate<br>Filtration<br>Efficiency<br>(PFE) | 32/32 Passed at ≥98% @ 0.1<br>micron<br>ASTM F2299 | 32/32 Passed at ≥98% @ 0.1<br>micron<br>ASTM F2299 | Pass at ≥98% @ 0.1<br>micron<br>ASTM F2299 | Same |
| Fluid<br>Resistance | 32/32 Passed at 160mm Hg<br>ASTM F1862 | 32/32 Passed at 160mm Hg<br>ASTM F1862 | Fluid Resistant 160mm Hg<br>ASTM F1862 | Same |
| Bacterial<br>Filtration<br>Efficiency<br>(BFE) | 31/32 Passed at ≥98%<br>ASTM F2101 | 31/32 Passed at ≥98%<br>ASTM F2101 | Pass at ≥98%<br>ASTM F2101 | Same |
| Differential<br>Pressure | 32/32 Passed at <5 mmH2O/cm²<br>MIL-M36954C | 32/32 Passed at <5 mmH2O/cm²<br>MIL-M36954C | Pass at <5 mmH2O/cm²<br>MIL-M36954C | Same |
| Flammability | 5/5 Passed ≥3 Seconds burn<br>time - Class 1<br>CFR 16 1610 | 5/5 Passed ≥3 Seconds burn<br>time - Class 1<br>CFR 16 1610 | Class 1<br>CFR 16 1610 | Same |
| Biocompatibility | | | | |
| Results | Non-cytotoxic, Non-<br>sensitizing, Non-irritating | Non-cytotoxic, Non-<br>sensitizing, Non-irritating | Non-cytotoxic, Non-<br>sensitizing, Non- irritating | Same |

The following standards have been met for the 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask

| 3M High Fluid-Resistant Procedure Mask | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM F2100 | Standard Specification for Performance of Materials Used in Medical Face Masks |
| ASTM F1862 | Standard Test Method for Resistance of Medical Face Masks to Penetration by<br>Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
| ASTM F2299 | Standard Test Method for Determining the Initial Efficiency of Materials Used in<br>Medical Face Masks to Penetration by Particulates Using Latex Spheres |
| ASTM F2101 | Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of<br>Medical Face Mask Materials, Using a Biological Aerosol of <i>Staphylococcus aureus</i> |
| MIL-M- 36954C | Military Specification, Mask, Surgical, Disposable |
| 16 CFR Part 1610 | Standard for the Flammability of Clothing |
| ISO10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a<br>risk management process |
| ISO10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity<br>of medical devices |
| ISO10993-10 | Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin |

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## Conclusion:

The conclusion drawn from the nonclinical tests demonstrates that the subject devices in 510(K) submission K191355, the 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask are as safe, as effective, and performs as well as or better than the legally marketed predicate device K131879.