LM Surgical Mask Level 3, LM Surgical Mask Level 2,
Device Facts
| Record ID | K211378 |
|---|---|
| Device Name | LM Surgical Mask Level 3, LM Surgical Mask Level 2, |
| Applicant | Liberty Mask, LLC |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Dec 16, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The following Liberty Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These are single use, disposable device(s) provided non-sterile.
Device Story
LM Surgical Masks (Level 2 and 3) are single-use, three-layer, pleated, non-sterile face masks. Construction includes inner/outer spun-bond polypropylene layers and a middle melt-blown polypropylene filter layer. A polypropylene-coated steel wire nose piece allows for facial fit; elastic ear loops secure the mask. Used in clinical settings by healthcare personnel and patients to reduce exposure to blood, body fluids, and particulates. No electronic components or software.
Clinical Evidence
Bench testing only. Performance evaluated per ASTM F2100-11 standards: Fluid Resistance (ASTM F1862), Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (MIL-M-36954C), and Flammability (16 CFR 1610). All results met acceptance criteria.
Technological Characteristics
Three-layer pleated mask; inner/outer layers: spun-bond polypropylene; middle layer: melt-blown polypropylene; nose piece: polypropylene-coated steel wire; ear loops: spandex elastic cord (polyurethane terephthalate/nylon). Non-sterile, single-use. No software or electronic components.
Indications for Use
Indicated for adults to protect patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material; intended for infection control to reduce exposure to blood and body fluids.
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
- Disposable Surgical Face Mask Ear Loop and Tie-On (K153496)
Submission Summary (Full Text)
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December 16, 2021
Liberty Mask LLC % Timothy Kania Consultant mdi Consultants 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K211378
Trade/Device Name: LM Surgical Mask Level 3, LM Surgical Mask Level 2 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 3, 2021 Received: May 4, 2021
Dear Timothy Kania:
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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542 of the Act); 21 CFR 1000-1050.
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-
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, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K211378
Device Name LM Surgical Mask Level 2 LM Surgical Mask Level 3
### Indications for Use (Describe)
The following Liberty Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
These are single use, disposable device(s) provided non-sterile.
LM Surgical Mask Level 3, Model #: LM0787 LM Surgical Mask Level 2, Model #: LM0786
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
The assigned 510(k) number is: K211378
## 1. Submitter's Identification:
Manufacturer: Liberty Mask, LLC Address: 1819 Firman Drive, Suite 101 Plano, Texas 75081
Contact: Mr. Will Kincaid Title: Operations Manager Phone Number: 214-915-2133 Email: willk@Libertymask.com
Date Summary Prepared: April 15, 2021
Official Correspondent: Mr. Tim Kania mdi Consultants, Inc. Phone Number: (732)-796-4565 Email: tim@mdiconsultants.com
## 2. Name of the Device:
| Device Name(s): | LM Surgical Mask Level 3, LM Surgical Mask Level 2 |
|-----------------|----------------------------------------------------|
| Model Number: | LM0787, LM0786 |
Common Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX
#### 3. Information for the 510(k) Cleared Device (Predicate Device):
### Predicate Device:
Disposable Surgical Face Mask Ear Loop and Tie-On K153496 Xiantao Rayxin Medical Products
#### 4. Device Description:
The LM Surgical Masks are white, single use, three-layer, pleated masks that come in 2 models: LM Surgical Mask Level 3 & LM Surgical Mask Level 2. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene. The masks are held in place over the users' mouth and nose by either two elastic ear loops, welded to the facemask.
The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose. The nose piece is made of polypropylene coated steel wire.
The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
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Two models will be sold:
LM Surgical Mask Level 3, Model #: LM0787 LM Surgical Mask Level 2, Model #: LM0786
The models are identical except for labeling.
#### 5. Indications for Use:
The following Liberty Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
These are single use, disposable device(s) provided non-sterile.
LM Surgical Mask Level 3, Model #: LM0787 LM Surgical Mask Level 2, Model #: LM0786
### 6. Comparison to the 510(k) Cleared Devices (Predicate Devices):
| Device | Proposed device | Predicate device | Result | |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| 510(k) Holder | Liberty Mask, LLC | Xiantao Rayxin Medical Products | -- | |
| 510(k)<br>Number | K211378 | K153496 | -- | |
| Name | LM Surgical Mask Level 2<br>Model #: LM0786<br>LM Surgical Mask Level 3<br>Model #: LM0787 | Disposable Surgical Face Mask<br>Ear Loop and Tie-On | -- | |
| Classification | Class II Device, FXX (21 CFR<br>878.4040) | Class II Device, FXX (21 CFR<br>878.4040) | Same | |
| Intended use | The following Liberty Surgical Face<br>Masks are intended to be worn to<br>protect both the patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids and<br>particulate material. These masks are<br>intended for use in infection control<br>practices to reduce the potential<br>exposure to blood and body fluids.<br>These are single use, disposable<br>device(s) provided non-sterile.<br>LM Surgical Mask Level 2 | The Disposable Surgical Face Masks are<br>intended to be worn to protect both the<br>patient and healthcare personnel from<br>transfer of microorganisms, body fluids<br>and particulate material. These face masks<br>are intended for use in infection control<br>practices to reduce the potential exposure<br>to blood and body fluids. This is a single<br>use, disposable device(s), provided non-<br>sterile | Same | |
| | Model #: LM0786<br>LM Surgical Mask Level 3<br>Model #: LM0787<br>Flat- Pleated | | | |
| Mask style | | Flat - Pleated | Same | |
| Design | Ear loop | Ear loop, Tie-On | Same | |
| Layers | Three | Three | Same | |
| Color | White<br>Standridge White 20790<br>CAS#13463-67-7 | Blue | Different<br>but<br>mitigated<br>through<br>biocompati<br>bility<br>testing | |
| Target<br>population | Adults | Adults | Same | |
| Dimension<br>(Length) | 17.0 cm +/- 4mm | 17.5 cm | Different | |
| Dimension<br>(Width) | 9.0 cm +/- 4mm | 9.5 cm | | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Use | Single use, disposable | Single use, disposable | Same | |
| Anatomical<br>site | Nose and mouth | Nose and mouth | Same | |
| Environment<br>of use | OTC | OTC | Same | |
| Material | | | | |
| Outer facing<br>layer | Spun bond Polypropylene | Spun bond Polypropylene | Same | |
| Middle layer | Melt blown polypropylene Filter | Melt blown polypropylene Filter | Same | |
| Inner facing<br>layer | Spun bond Polypropylene | Spun bond Polypropylene | Same | |
| Ear Loops | Spandex Elastic Cord. (Polyurethane<br>terephthalate/nylon cover) | Polyester | Different<br>but<br>mitigated<br>through<br>biocompati<br>bility<br>testing | |
| Nose piece | Polypropylene Coated Steel Wire | Malleable aluminum wire | Different<br>but<br>mitigated<br>through<br>biocompati<br>bility<br>testing | |
| ASTM F2100<br>Level | Level 2 & 3 | Level 2 | bility<br>testing<br>Different.<br>No new<br>issues of<br>safety or<br>effectivenes<br>s and higher<br>protection<br>provided by<br>Proposed<br>Device | |
| Performance Testing Results | | | | |
| Performance<br>tests | Subject device | Predicate device | Acceptance<br>Criteria | Result |
| Fluid<br>Resistance<br>Performance<br>ASTM F1862 | LM Surgical Mask Level 3, LM0787:<br>95 out of 96 samples passed from 3<br>nonconsecutive lots at 160mm Hg<br>LM Surgical Mask Level 2, LM0786:<br>96 out of 96 samples passed from 3<br>nonconsecutive lots at 160mm Hg | 32 out of 32 Pass<br>at<br>160mm Hg | 29 out of 32 pass<br>at 160mmHg | Similar &<br>Acceptable |
| Particulate<br>Filtration<br>Efficiency<br>ASTM F2299 | LM Surgical Mask Level 3, LM0787:<br>96 out of 96 passed from 3<br>nonconsecutive lots at an average of<br>99.09%<br>LM Surgical Mask Level 2, LM0786:<br>96 out of 96 passed from 3<br>nonconsecutive lots at an average of<br>98.42% | 99.67% | ≥ 98% | Similar &<br>Acceptable |
| Bacterial<br>Filtration<br>Efficiency<br>ASTM F2101 | LM Surgical Mask Level 3, LM0787:<br>96 out of 96 passed from 3<br>nonconsecutive lots at an average of<br>99.60%<br>LM Surgical Mask Level 2, LM0786:<br>96 out of 96 passed from 3<br>nonconsecutive lots at an average of<br>99.59% | 99.95% | ≥ 98% | Similar &<br>Acceptable |
| Differential<br>Pressure<br>(Delta-P)<br>MIL-M-<br>36954C | LM Surgical Mask Level 3, LM0787:<br>$4.80mmH2O/cm^2$<br>LM Surgical Mask Level 2, LM0786:<br>$5.20mmH2O/cm^2$ | $5.62mmH2O/cm^2$ | $<6.0mmH2O/cm^2$ | Similar &<br>Acceptable |
| Flammability<br>class 16CFR<br>1610 | The test was performed in accordance<br>with 16 CFR 1610 STANDARD FOR<br>THE FLAMMABILITY OF<br>CLOTHING TEXTILES to evaluate<br>the flammability of the test sample.<br>Class I<br>LM Surgical Mask Level 3, LM0787:<br>96 out of 96 passed from 3<br>nonconsecutive lots at Class 1<br>LM Surgical Mask Level 2, LM0786:<br>96 out of 96 passed from 3<br>nonconsecutive lots at Class 1 | Class 1 | Class 1 | Similar &<br>Acceptable |
| Biocompatibility (limited contact (<24h) surface devices on intact skin) | | | | |
| Cytotoxicity | Under the conditions of the study, the<br>proposed device extract was<br>determined to be non-cytotoxic. | Under the conditions of the study, the<br>predicate device extract was<br>determined to be non-cytotoxic. | | Same |
| Irritation | Under the conditions of the study, the<br>proposed device non-polar and polar<br>extracts were determined to be non-<br>irritating. | Under the conditions of the study, the<br>predicate device non-polar and polar<br>extracts were determined to be non-<br>irritating. | | Same |
| Sensitization | Under the conditions of the study, the<br>proposed device non-polar and polar<br>extracts were determined to be non-<br>sensitizing. | Under the conditions of the study, the<br>predicate device non-polar and polar<br>extracts were determined to be non-<br>sensitizing. | | Same |
## Table 2: Comparison to Predicate Device
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### 7. Summary of Non-Clinical Testing
| Standard | Test Methodology | Purpose | Acceptance Criteria | Results |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fluid Resistance<br>Performance<br>ASTM F1862 | An arterial spray is<br>simulated by the<br>testing laboratory<br>by spraying<br>synthetic blood at<br>a pressure of<br>160mm Hg. The<br>test articles are hen<br>examined to<br>determine if any<br>blood penetration<br>has occurred. | This test is<br>performed to<br>evaluate<br>Personal<br>Protective<br>Equipment<br>against fluid<br>penetration. An<br>arterial spray is<br>simulated to test<br>the PPE. | 29 out of 32 pass<br>at 160mmHg | LM Surgical Mask<br>Level 3, LM0787:<br>95 out of 96 samples<br>passed from 3<br>nonconsecutive lots<br>at 160mm Hg<br>LM Surgical Mask<br>Level 2, LM0786: 96<br>out of 96 samples<br>passed from 3<br>nonconsecutive lots<br>at 160mm Hg |
| Particulate Filtration<br>Efficiency<br>ASTM F2299 | Monodispersed<br>PSL are nebulized,<br>dried and passed<br>through the test | The PFE test is<br>performed to<br>evaluate the<br>non-viable | ≥ 98% | LM Surgical Mask<br>Level 3, LM0787: 96<br>out of 96 passed<br>from 3 |
| | article. The<br>particles that<br>passed through the<br>test article are<br>enumerated by a<br>laser particle<br>counter. | particle filtration<br>efficiency of the<br>test article. | | nonconsecutive lots<br>at an average of<br>99.09%<br>LM Surgical Mask<br>Level 2, LM0786: 96<br>out of 96 passed<br>from 3<br>nonconsecutive lots<br>at an average of<br>98.42% |
| Bacterial Filtration<br>Efficiency<br>ASTM F2101 | The BFE test is<br>performed by<br>comparing the<br>bacterial control<br>counts upstream to<br>the bacterial<br>counts downstream<br>of the test article. | The BFE test is<br>performed to<br>determine the<br>bacterial<br>filtration<br>efficiency of test<br>articles. | ≥ 98% | LM Surgical Mask<br>Level 3, LM0787: 96<br>out of 96 passed<br>from 3<br>nonconsecutive lots<br>at an average of<br>99.60%<br>LM Surgical Mask<br>Level 2, LM0786: 96<br>out of 96 passed<br>from 3<br>nonconsecutive lots<br>at an average of<br>99.59% |
| Differential Pressure<br>(Delta-P)<br>MIL-M-36954C | A controlled flow<br>of air is driven<br>through a sample<br>of the test article<br>containing all<br>layers. The<br>pressure before<br>and after the<br>sample is<br>measured; the<br>difference in<br>pressure is divided<br>by the surface (in<br>cm2) of the<br>sample. | The purpose of<br>this test is to<br>ensure the drop<br>in pressure is<br>not too great so<br>the user may<br>breathe through<br>the subject<br>device. | <6.0mmH2O/cm² | LM Surgical Mask<br>Level 3, LM0787:<br>4.80mmH2O/cm²<br>LM Surgical Mask<br>Level 2, LM0786:<br>5.20mmH2O/cm² |
| Flammability class<br>16CFR 1610 | The test articles<br>are exposed to a<br>flame to determine<br>if they ignite and<br>for how long they<br>burn if ignited. | The purpose of<br>this test is to<br>ensure the<br>subject device<br>does not ignite<br>when exposed to<br>flame. | Class 1 | The test was<br>performed in<br>accordance with 16<br>CFR 1610<br>STANDARD FOR<br>THE<br>FLAMMABILITY |
| | | | OF CLOTHING<br>TEXTILES to<br>evaluate the<br>flammability of the<br>test sample. Class I | |
| | | | LM Surgical Mask<br>Level 3, LM0787: 96<br>out of 96 passed<br>from 3<br>nonconsecutive lots<br>at Class 1 | |
| | | | LM Surgical Mask<br>Level 2, LM0786: 96<br>out of 96 passed<br>from 3<br>nonconsecutive lots<br>at Class 1 | |
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The performance test results for the LM Surgical Masks meets ASTM F2100-11 Level 3 acceptance criteria. The results demonstrating the safety and effectiveness of the LM surgical masks in their intended environment of use were determined in accordance with the FDA 2004 guidance "Surgical Masks - Premarket Notification [510(k)] Submissions", which outlines performance requirements for surgical masks.
#### 8. Discussion of Clinical Tests Performed:
The conclusion drawn from the nonclinical tests demonstrates that the proposed device in 510(K) submission, the LM Surgical Masks (K211378) are as safe, as effective, and performs as well as or better than the legally marketed predicate device K153496.
