(226 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the "LM Surgical Mask Level 2" and "LM Surgical Mask Level 3," based on the provided FDA 510(k) summary:
This document describes a medical device clearance for surgical masks. These devices are typically evaluated through bench testing (non-clinical) to meet specific performance standards, rather than full clinical trials with patient outcomes. Therefore, most of the questions relating to clinical study design (experts, adjudication, MRMC, human-in-the-loop, training set details) are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Test | Acceptance Criteria (LM Surgical Mask Level 3 for PFE, BFE, Delta-P, and for Level 2 & 3 Flammability) | Reported Device Performance (LM Surgical Mask Level 3) | Acceptance Criteria (LM Surgical Mask Level 2) | Reported Device Performance (LM Surgical Mask Level 2) | Overall Result |
|---|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 160mmHg | 95 out of 96 samples passed (from 3 nonconsecutive lots) at 160mm Hg | 29 out of 32 pass at 160mmHg | 96 out of 96 samples passed (from 3 nonconsecutive lots) at 160mm Hg | Similar & Acceptable |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Average of 99.09% (96 out of 96 passed from 3 nonconsecutive lots) | ≥ 98% | Average of 98.42% (96 out of 96 passed from 3 nonconsecutive lots) | Similar & Acceptable |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Average of 99.60% (96 out of 96 passed from 3 nonconsecutive lots) | ≥ 98% | Average of 99.59% (96 out of 96 passed from 3 nonconsecutive lots) | Similar & Acceptable |
| Differential Pressure (Delta-P) (MIL-M-36954C) | <6.0mmH2O/cm² | 4.80mmH2O/cm² | <6.0mmH2O/cm² | 5.20mmH2O/cm² | Similar & Acceptable |
| Flammability (16CFR 1610) | Class 1 | Class 1 (96 out of 96 passed from 3 nonconsecutive lots) | Class 1 | Class 1 (96 out of 96 passed from 3 nonconsecutive lots) | Similar & Acceptable |
| Biocompatibility: Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic | Same (as predicate) |
| Biocompatibility: Irritation | Non-irritating | Non-irritating (non-polar and polar extracts) | Non-irritating | Non-irritating (non-polar and polar extracts) | Same (as predicate) |
| Biocompatibility: Sensitization | Non-sensitizing | Non-sensitizing (non-polar and polar extracts) | Non-sensitizing | Non-sensitizing (non-polar and polar extracts) | Same (as predicate) |
2. Sample Size Used for the Test Set and Data Provenance:
- Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Flammability: For each model (LM Surgical Mask Level 3 and LM Surgical Mask Level 2), 96 samples were tested, drawn from 3 nonconsecutive lots.
- Differential Pressure: Not explicitly stated how many samples per model, but the results are reported as single values (4.80 mmH2O/cm² and 5.20 mmH2O/cm²), which typically represent an average of multiple samples.
- Biocompatibility: The specific sample sizes for cytotoxicity, irritation, and sensitization tests are not detailed, but these tests are generally conducted on extracts from the device material.
- Data Provenance: The tests are non-clinical (bench testing) and were performed by the manufacturer or a contracted lab. The document does not specify the country of origin of the data beyond the manufacturer's address in Plano, Texas. These are prospective tests conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. For surgical mask performance evaluations, ground truth is established by standardized laboratory test methods (e.g., ASTM, MIL-M) that provide objective, measurable outcomes, not by expert interpretation of images or observations.
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective laboratory measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a medical device clearance for physical surgical masks, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used:
The ground truth is based on objective measurements from standardized laboratory tests (e.g., fluid penetration, particle count, bacterial colony count, pressure differential, burn time, cellular response for biocompatibility). These standards (ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610, and ISO 10993 for biocompatibility) define the methodology and expected results.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. (See #8)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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)Number | K211378 | K153496 | -- | |
| Name | LM Surgical Mask Level 2Model #: LM0786LM Surgical Mask Level 3Model #: LM0787 | Disposable Surgical Face MaskEar Loop and Tie-On | -- | |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same | |
| Intended use | The following Liberty Surgical FaceMasks are intended to be worn toprotect both the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These masks areintended for use in infection controlpractices to reduce the potentialexposure to blood and body fluids.These are single use, disposabledevice(s) provided non-sterile.LM Surgical Mask Level 2 | The Disposable Surgical Face Masks areintended to be worn to protect both thepatient and healthcare personnel fromtransfer of microorganisms, body fluidsand particulate material. These face masksare intended for use in infection controlpractices to reduce the potential exposureto blood and body fluids. This is a singleuse, disposable device(s), provided non-sterile | Same | |
| Model #: LM0786LM Surgical Mask Level 3Model #: LM0787Flat- Pleated | ||||
| Mask style | Flat - Pleated | Same | ||
| Design | Ear loop | Ear loop, Tie-On | Same | |
| Layers | Three | Three | Same | |
| Color | WhiteStandridge White 20790CAS#13463-67-7 | Blue | Differentbutmitigatedthroughbiocompatibilitytesting | |
| Targetpopulation | Adults | Adults | Same | |
| Dimension(Length) | 17.0 cm +/- 4mm | 17.5 cm | Different | |
| Dimension(Width) | 9.0 cm +/- 4mm | 9.5 cm | ||
| Sterility | Non-sterile | Non-sterile | Same | |
| Use | Single use, disposable | Single use, disposable | Same | |
| Anatomicalsite | Nose and mouth | Nose and mouth | Same | |
| Environmentof use | OTC | OTC | Same | |
| Material | ||||
| Outer facinglayer | Spun bond Polypropylene | Spun bond Polypropylene | Same | |
| Middle layer | Melt blown polypropylene Filter | Melt blown polypropylene Filter | Same | |
| Inner facinglayer | Spun bond Polypropylene | Spun bond Polypropylene | Same | |
| Ear Loops | Spandex Elastic Cord. (Polyurethaneterephthalate/nylon cover) | Polyester | Differentbutmitigatedthroughbiocompatibilitytesting | |
| Nose piece | Polypropylene Coated Steel Wire | Malleable aluminum wire | Differentbutmitigatedthroughbiocompatibilitytesting | |
| ASTM F2100Level | Level 2 & 3 | Level 2 | bilitytestingDifferent.No newissues ofsafety oreffectiveness and higherprotectionprovided byProposedDevice | |
| Performance Testing Results | ||||
| Performancetests | Subject device | Predicate device | AcceptanceCriteria | Result |
| FluidResistancePerformanceASTM F1862 | LM Surgical Mask Level 3, LM0787:95 out of 96 samples passed from 3nonconsecutive lots at 160mm HgLM Surgical Mask Level 2, LM0786:96 out of 96 samples passed from 3nonconsecutive lots at 160mm Hg | 32 out of 32 Passat160mm Hg | 29 out of 32 passat 160mmHg | Similar &Acceptable |
| ParticulateFiltrationEfficiencyASTM F2299 | LM Surgical Mask Level 3, LM0787:96 out of 96 passed from 3nonconsecutive lots at an average of99.09%LM Surgical Mask Level 2, LM0786:96 out of 96 passed from 3nonconsecutive lots at an average of98.42% | 99.67% | ≥ 98% | Similar &Acceptable |
| BacterialFiltrationEfficiencyASTM F2101 | LM Surgical Mask Level 3, LM0787:96 out of 96 passed from 3nonconsecutive lots at an average of99.60%LM Surgical Mask Level 2, LM0786:96 out of 96 passed from 3nonconsecutive lots at an average of99.59% | 99.95% | ≥ 98% | Similar &Acceptable |
| DifferentialPressure(Delta-P)MIL-M-36954C | LM Surgical Mask Level 3, LM0787:$4.80mmH2O/cm^2$LM Surgical Mask Level 2, LM0786:$5.20mmH2O/cm^2$ | $5.62mmH2O/cm^2$ | $<6.0mmH2O/cm^2$ | Similar &Acceptable |
| Flammabilityclass 16CFR1610 | The test was performed in accordancewith 16 CFR 1610 STANDARD FORTHE FLAMMABILITY OFCLOTHING TEXTILES to evaluatethe flammability of the test sample.Class ILM Surgical Mask Level 3, LM0787:96 out of 96 passed from 3nonconsecutive lots at Class 1LM Surgical Mask Level 2, LM0786:96 out of 96 passed from 3nonconsecutive lots at Class 1 | Class 1 | Class 1 | Similar &Acceptable |
| Biocompatibility (limited contact (<24h) surface devices on intact skin) | ||||
| Cytotoxicity | Under the conditions of the study, theproposed device extract wasdetermined to be non-cytotoxic. | Under the conditions of the study, thepredicate device extract wasdetermined to be non-cytotoxic. | Same | |
| Irritation | Under the conditions of the study, theproposed device non-polar and polarextracts were determined to be non-irritating. | Under the conditions of the study, thepredicate device non-polar and polarextracts were determined to be non-irritating. | Same | |
| Sensitization | Under the conditions of the study, theproposed device non-polar and polarextracts were determined to be non-sensitizing. | Under the conditions of the study, thepredicate device non-polar and polarextracts were determined to be non-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 ResistancePerformanceASTM F1862 | An arterial spray issimulated by thetesting laboratoryby sprayingsynthetic blood ata pressure of160mm Hg. Thetest articles are henexamined todetermine if anyblood penetrationhas occurred. | This test isperformed toevaluatePersonalProtectiveEquipmentagainst fluidpenetration. Anarterial spray issimulated to testthe PPE. | 29 out of 32 passat 160mmHg | LM Surgical MaskLevel 3, LM0787:95 out of 96 samplespassed from 3nonconsecutive lotsat 160mm HgLM Surgical MaskLevel 2, LM0786: 96out of 96 samplespassed from 3nonconsecutive lotsat 160mm Hg |
| Particulate FiltrationEfficiencyASTM F2299 | MonodispersedPSL are nebulized,dried and passedthrough the test | The PFE test isperformed toevaluate thenon-viable | ≥ 98% | LM Surgical MaskLevel 3, LM0787: 96out of 96 passedfrom 3 |
| article. Theparticles thatpassed through thetest article areenumerated by alaser particlecounter. | particle filtrationefficiency of thetest article. | nonconsecutive lotsat an average of99.09%LM Surgical MaskLevel 2, LM0786: 96out of 96 passedfrom 3nonconsecutive lotsat an average of98.42% | ||
| Bacterial FiltrationEfficiencyASTM F2101 | The BFE test isperformed bycomparing thebacterial controlcounts upstream tothe bacterialcounts downstreamof the test article. | The BFE test isperformed todetermine thebacterialfiltrationefficiency of testarticles. | ≥ 98% | LM Surgical MaskLevel 3, LM0787: 96out of 96 passedfrom 3nonconsecutive lotsat an average of99.60%LM Surgical MaskLevel 2, LM0786: 96out of 96 passedfrom 3nonconsecutive lotsat an average of99.59% |
| Differential Pressure(Delta-P)MIL-M-36954C | A controlled flowof air is driventhrough a sampleof the test articlecontaining alllayers. Thepressure beforeand after thesample ismeasured; thedifference inpressure is dividedby the surface (incm2) of thesample. | The purpose ofthis test is toensure the dropin pressure isnot too great sothe user maybreathe throughthe subjectdevice. | <6.0mmH2O/cm² | LM Surgical MaskLevel 3, LM0787:4.80mmH2O/cm²LM Surgical MaskLevel 2, LM0786:5.20mmH2O/cm² |
| Flammability class16CFR 1610 | The test articlesare exposed to aflame to determineif they ignite andfor how long theyburn if ignited. | The purpose ofthis test is toensure thesubject devicedoes not ignitewhen exposed toflame. | Class 1 | The test wasperformed inaccordance with 16CFR 1610STANDARD FORTHEFLAMMABILITY |
| OF CLOTHINGTEXTILES toevaluate theflammability of thetest sample. Class I | ||||
| LM Surgical MaskLevel 3, LM0787: 96out of 96 passedfrom 3nonconsecutive lotsat Class 1 | ||||
| LM Surgical MaskLevel 2, LM0786: 96out of 96 passedfrom 3nonconsecutive lotsat 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.
§ 878.4040 Surgical apparel.
(a)
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.(b)
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.