← Product Code [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX) · K201844

# Surgical Face Mask, Surgical Mask (K201844)

_Lear Corporation · FXX · Jul 14, 2021 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K201844

## Device Facts

- **Applicant:** Lear Corporation
- **Product Code:** [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX.md)
- **Decision Date:** Jul 14, 2021
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Intended Use

The Surgical Face Mask is intended for single use by operating room personnel, patients, and other general healthcare workers to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. This is a non-sterile, single-use, disposable device.

## Device Story

Disposable, non-sterile, 3-layer surgical face mask; outer/inner layers spun-bond polypropylene; middle layer melt-blown polypropylene. Features pliable steel nose wire (polypropylene-coated) and ultrasonically welded nylon/spandex ear loops. Used by healthcare personnel and patients in clinical settings to provide barrier protection against microorganisms, blood, body fluids, and particulates. Device is worn over nose and mouth; nose wire facilitates fit. Provides fluid resistance and filtration of particulates/bacteria; reduces potential exposure to contaminants. Single-use, disposable design.

## Clinical Evidence

Bench testing only. Device tested against ASTM F2100-19 level 3 criteria: ASTM F1862 (fluid resistance 160 mmHg), ASTM F2101 (BFE 99.1%), ASTM F2299 (PFE 99.0%), EN 14683 (differential pressure 4.9 mmH2O/cm2), and 16 CFR Part 1610 (flammability Class 1). Biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization) passed.

## Technological Characteristics

3-layer construction: spun-bond polypropylene (inner/outer), melt-blown polypropylene (middle). Galvanized steel nose wire coated in polypropylene. Nylon/spandex ear loops. Flat pleated style. Dimensions: 6.89 in x 3.74 in. Non-sterile. No natural rubber latex.

## 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

- DemeMASK Surgical Mask ([K201479](/device/K201479.md))

## Submission Summary (Full Text)

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July 14, 2021

Lear Corporation Ryan Facer Product Development Engineer 1 Penn Dve St Pine Grove, Pennsylvania 17963

Re: K201844

Trade/Device Name: Disposable Surgical Face Mask, Surgical Face Mask, Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 15, 2021 Received: June 16, 2021

Dear Ryan Facer:

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

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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 (OS) 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,

Ryan Ortega, PhD Acting 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) K201844

Device Name

Disposable Surgical Face Mask, Surgical Face Mask, Surgical Mask

Indications for Use (Describe)

The Surgical Face Mask is intended for single use by operating room personnel, patients, and other general healtheare workers to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. This is a non-sterile, single use, disposable device.

| 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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# 5. 510(k) Summary Report

# K201844

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

Date Prepared: 06/10/2021

## 5.1. Submitter's Identification

Guilford Performance Textiles by Lear 1 Penn Dye St Pine Grove, PA 17963 USA

Contact Person: Ryan Facer Telephone: (336) 341-8687 Email: rfacer@lear.com

#### 5.2. Device & Regulatory Information

Trade Name: Disposable Surgical Face Mask, Surgical Face Mask, Surgical Mask Model Number: 69005 Common Name: Surgical Mask 510(k) Number: K201844 Classification Name: Mask, Surgical Classification: Class II Product Code: FXX Regulation Number: 21 CFR 878.4040

#### 5.3. Predicate Device

Submitter: DemeTECH Corporation 510(k) Number: K201479 Device Name: DemeMASK Surgical Mask

#### 5.4. Device Description:

The proposed Surgical Face Mask is a non-sterile, single-use, 3-layer mask with outer and inner facing layers comprised of white spun-bond polypropylene and a middle layer comprised of white melt blown polypropylene. The mask is secured to the user via nylon/spandex ear loops that are ultrasonically welded to the mask. This mask does not contain any natural rubber latex. The device also contains a nose wire made of a pliable steel strip, coated in polypropylene, that helps to form the mask around the user's nose.

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The types of materials used in the proposed Surgical Face Mask are currently being used in legally marketed devices.

#### 5.5. Contact

Type: Surface Device – Intact Skin Contact Duration: Limited – Less than 24 hours

## 5.6. Intended Use

The Surgical Face Mask is intended for single use by operating room personnel, patients, and other general healthcare workers to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. This is a non-sterile, single-use, disposable device.

## 5.7. Comparison to Predicate Device

#### 5.7.1. Intended Use/Indications for Use

| Proposed Surgical Face Mask<br>(K201844)                                                                                                                                                                                                                                                             | Predicate Surgical Mask<br>(K201479)                                                                                                                                                                                                                                                                                                                                                                                  | Comparison                                                                     |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| The Surgical Face Mask is intended<br>for single use by operating room<br>personnel, patients, and other<br>general healthcare workers to<br>protect against the transfer of<br>microorganisms, blood, bodily fluids,<br>and particulates. This is a non-<br>sterile, single use, disposable device. | The Disposable Surgical Face Masks<br>are intended to be worn to protect<br>both the patient and<br>healthcare personnel from transfer<br>of microorganisms, body fluids and<br>particulate material. These<br>face masks are intended for use in<br>infection control practices to<br>reduce the potential exposure to<br>blood and body fluids. This is a<br>single use, disposable device<br>provided non-sterile. | Intended use/<br>Indications for Use is<br>the same as the<br>predicate device |

#### 5.7.2. Materials, Technical Specifications, & Risks to Health

| Description | Proposed Surgical<br>Face Mask<br>(K201844) | Predicate Surgical<br>Mask<br>(K201479)               | Comparison                                     |                                    |
|-------------|---------------------------------------------|-------------------------------------------------------|------------------------------------------------|------------------------------------|
| Materials   | Inner Layer                                 | Spun-bond<br>polypropylene                            | Spun-bond<br>polypropylene                     | Same as the<br>predicate device    |
|             | Middle Layer                                | Melt blown<br>polypropylene                           | Melt blown<br>polypropylene                    | Same as the<br>predicate device    |
|             | Outer Layer                                 | Spun-bond<br>polypropylene                            | Spun-bond<br>polypropylene                     | Same as the<br>predicate device    |
|             | Nose Wire                                   | Galvanized steel wire<br>coated with<br>polypropylene | Galvanized wire<br>coated with<br>polyethylene | Similar to the<br>predicate device |

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|                                | Elastic ear-loops                                                                                    | Nylon & spandex                     | Nylon & spandex                     | Same as the<br>predicate device    |
|--------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------------|------------------------------------|
|                                | Mask Style                                                                                           | Flat Pleated                        | Flat pleated                        | Same as the<br>predicate device    |
| Specifications                 | Design Feature                                                                                       | Ear loops<br>(Length: 150 mm)       | Ear loops<br>(Length: not provided) | Similar to<br>predicate device     |
|                                | Nose Wire                                                                                            | Length: 110 mm                      | Info not provided                   | Similar to<br>predicate device     |
|                                | Mask Dimensions                                                                                      | Length - 6.89 in<br>Width – 3.74 in | Length - 6.89 in<br>Width — 3.74 in | Same as the<br>predicate device    |
| Performance<br>test<br>results | Fluid Resistance<br>ASTM 1862<br>(160 mmHg)                                                          | Pass                                | Pass                                | Same as the<br>predicate device    |
|                                | Particulate<br>Filtration<br>Efficiency<br>ASTM F2299<br>(0.1 micron)                                | Avg. 99.0%                          | ≥99%                                | Similar to the<br>predicate device |
|                                | Bacterial Filtration<br>Efficiency<br>ASTM F2101                                                     | Avg. 99.1%                          | ≥99%                                | Similar to the<br>predicate device |
|                                | Differential<br>Pressure<br>ASTM F2100-19                                                            | Avg. $4.9 mmH_2O/cm^2$              | * Avg. $3.6 mmH_2O/cm^2$            | Similar to<br>predicate device     |
|                                | Flammability<br>16 CFR Part 1610                                                                     | Class 1                             | Class 1                             | Same as the<br>predicate device    |
|                                | Biocompatibility<br>ISO 10993-5 & ISO<br>10993-10<br>(Cytotoxicity,<br>Irritation,<br>Sensitization) | Pass                                | Pass                                | Same as the<br>predicate device    |

*Predicate device was tested per MIL-M36954C.

#### 5.8. Summary of Nonclinical Testing

The proposed Surgical Face Masks have been tested according to ASTM F2100-19, the relevant standards which comprise ASTM F2100-19, and ISO 10993 in order to determine substantial equivalence. The following tests were conducted on the proposed Surgical Face Masks:

- ASTM F1862 Test Method for Resistance of Medical Face Masks to Penetration l. by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

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- II. ASTM F2101 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- III. ASTM F2299 Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- IV. EN 14683:2019, Annex C Method for Determination of Breathability (Differential Pressure)
- V. 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- VI. ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity
- VII. ISO 10993-10 Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization

All results of testing met ASTM F2100-19 level 3 acceptance criteria.

# 5.9. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K201844, the Surgical Face Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201479.

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K201844](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K201844)

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