(100 days)
The Disposable Medical Face Mask (Model:LT0819, Ear loops) 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 the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The Proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all have Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene, iron and zinc. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document describes the acceptance criteria and performance of the "Disposable Medical Face Mask (Model:LT0819, Ear loops)" manufactured by Shenzhen Lyttop Healthcare Limited. The device is classified as a Class II surgical apparel (21 CFR 878.4040) with product code FXX.
1. Table of Acceptance Criteria and Reported Device Performance
The device underwent non-clinical testing to demonstrate its performance against recognized standards, specifically for Level 2 medical masks according to ASTM F2100.
| Test Methodology | Purpose | Acceptance Criteria (Level 2) | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | To demonstrate the functionality of the subject device. | 29 out of 32 Pass at 120 mmHg | 3 lots, 32 out of 32 passes at 120 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate the functionality of the subject device. | ≥ 98% | 98.69%; 99.43%; 99.41% (for three lots) |
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate the functionality of the subject device. | ≥ 98% | 99.89%; 99.9%; 99.9% (for three lots) |
| Differential Pressure (Delta P) (EN 14683 Annex C) | To demonstrate the functionality of the subject device. | < 6.0 mmH₂O/cm² | 2.9 mm H₂O/cm²; 3.3 mm H₂O/cm²; 3.3 mm H₂O/cm² (for three lots) |
| Flammability (16 CFR 1610) | To demonstrate the functionality of the subject device. | Class 1 | Class 1; Class 1; Class 1 (for three lots) |
| Biocompatibility - Cytotoxicity (ISO 10993-5) | To demonstrate the biocompatibility of the subject device. | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Biocompatibility - Irritation (ISO 10993-10) | To demonstrate the biocompatibility of the subject device. | Non-Irritating | Under the conditions of the study, the device is non-irritating. |
| Biocompatibility - Sensitization (ISO 10993-10) | To demonstrate the biocompatibility of the subject device. | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates that for performance testing, "3 lots" of the device were tested. For Fluid Resistance, 32 samples from each lot were tested (e.g., "32 out of 32 passes"). The specific sample sizes for other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) are not explicitly stated as individual sample counts but are reported as percentages or numerical values per lot.
The data provenance is from non-clinical tests conducted to verify the device's performance against established standards. The country of origin for the testing data is not explicitly stated, but the manufacturer is Shenzhen Lyttop Healthcare Limited, China. The testing is retrospective in the sense that it's conducted on manufactured product samples to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This section is not applicable as the document describes non-clinical performance and biocompatibility testing of a medical device (face mask), not an AI or diagnostic device that requires expert ground truth establishment for a test set. The "ground truth" here is defined by objective physical and biological test standards (e.g., specific filtration percentages, pressure differentials, and toxicity levels).
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. The evaluation is based on direct measurement against predefined scientific and engineering criteria, not subjective expert judgment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging or AI devices in assisting human readers, which is not the nature of a disposable medical face mask.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone "algorithm-only" performance study was not done. The device is a physical medical face mask, not a software algorithm or AI system.
7. The Type of Ground Truth Used
For the performance tests, the "ground truth" used is based on objective, quantitative measurements against established national and international standards.
- Performance (Filtration Efficiency, Fluid Resistance, Differential Pressure, Flammability): The ground truth is defined by the specific thresholds and methodologies outlined in standards such as ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, and 16 CFR 1610. These standards provide clear, measurable criteria for acceptable performance.
- Biocompatibility: The ground truth is defined by the biological response observed in standardized in vitro (cytotoxicity) and in vivo (irritation, sensitization) tests following ISO 10993 guidelines, where "non-cytotoxic," "non-irritating," and "non-sensitizing" are the accepted outcomes.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical product (a face mask) and does not involve an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
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August 11, 2021
Shenzhen Lyttop Healthcare Limited % Ivy Wang Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K211353
Trade/Device Name: Disposable Medical Face Mask (Model:LT0819, Ear loops) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 6, 2021 Received: July 6, 2021
Dear Ivy Wang:
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.
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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 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.
For Clarence W. Murray, III, PhD 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) K211353
Device Name
Disposable Medical Face Mask (Model:LT0819, Ear loops)
Indications for Use (Describe)
The Disposable Medical Face Mask (Model:LT0819, Ear loops) 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 the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
| 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
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Shenzhen Lyttop Healthcare Limited
A201, Building 7, Dongjiu Innovation and Technology Park II, No.73, Xiali South Road, Xiali Lang Community, Nanwan Street, Longgang District, Shenzhen 518114
510(K) Summary K211353
A. Applicant:
Name: Shenzhen Lyttop Healthcare Limited Address: A201, Building 7, Dongjiu Innovation and Technology Park II, No.73, Xiali South Road, Xiali Lang Community, Nanwan Street, Longgang District, Shenzhen, 518114 Contact Person: Lily Wu Tel: +86-0755-22951616 Email: lyttop@lyttop.com Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device:
Trade Name: Disposable Medical Face Mask (Model:LT0819, Ear loops)
Common Name: Surgical Face Mask
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number:878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K203426 Surgical Face Mask(Non-sterile)
D. Indications for Use:
The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare
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Shenzhen Lyttop Healthcare Limited A201, Building 7, Dongjiu Innovation and Technology Park II, No.73, Xiali South Road, Xiali Lang Community, Nanwan Street, Longgang District, Shenzhen 518114
personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
E. Device Description:
The Proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all have Nose clips design for fitting the face mask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene, iron and zinc. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
F. Comparison with predicate device
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| Manufacturer | Shenzhen Lyttop Healthcare Limited | Nantong Taiweishi MedicalTechnology Co., Ltd. | - |
| 510K number | K211353 | K203426 | - |
| Model name | Disposable Medical Face Mask(Model:LT0819, Ear loops) | Surgical Face Mask(Non-sterile) | - |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Same |
| Intended use | The Disposable Medical Face Mask(Model:LT0819, Ear loops) isintended to be worn to protect boththe patient and healthcare personnelfrom transfer of microorganisms,body fluids and particulate material.These face masks are intended foruse in infection control practices toreduce the potential exposure toblood and body fluids. This a singleuse, disposable device(s), providednon-sterile. | The Surgical Face Mask(non-sterile) is intended to be worn toprotect both the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These face masksare intended for use in infection controlpractices to reduce the potentialexposure to blood and body fluids. Thisa single use, disposable device(s),provided non-sterile. | Same |
| Model | Ear loop, Flat pleated,3 layers | Ear loop, Flat pleated,3 layers | Same |
| Outerlayer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
Table 1 General Comparison
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Shenzhen Lyttop Healthcare Limited
| A201, Building 7, Dongjiu Innovation and Technology Park II, No.73, Xiali South Road, Xiali Lang Community, Nanwan | |||||
|---|---|---|---|---|---|
| Street, Longgang District, Shenzhen 518114 | |||||
| Middlelayer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
|---|---|---|---|---|
| Material | Innerlayer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Noseclip | Polypropylene,iron and zinc | Polyethylene | Different | |
| Earloops | Nylon and Spandex | Nylon and Spandex | Same | |
| Color | Blue | Blue | Same | |
| Dimension | 175mm ±5mm | 175mm+/-5% | Similar | |
| Dimension (Width) | 95mm±5mm | 95mm+/-5% | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 level | Level 2 | Level 2 | Same | |
| Biocompatibility | ISO10993 | ISO10993 | Same |
From the comparison we found the material of the current nose clip was different from the predicate device. The biocompatibility tests were conducted to both components to ensure their compliance to the ISO10993-5 and ISO10993-10. There is no new risk generated from the difference of the material.
For the Performance testing, the test results are not identical to each other, but they are similar.Both of them meet the requirement of Level 2 medical mask according to the ASTM F2100.
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with 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 ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
- A 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 Synthetic Blood (Horizontal Projection of Fixed Volume at A KnownVelocity);
- EN 14683, Medical Face Masks-Requirements and Test Methods; A
- ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE)Of A Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
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Shenzhen Lyttop Healthcare Limited
A201, Building 7, Dongjiu Innovation and Technology Park II, No.73, Xiali South Road, Xiali Lang Community, Nanwan Street, Longgang District, Shenzhen 518114
- A ASTM F2299, stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
-
16 CFR 1610, Standard for the Flammability of clothing textiles;
| Test Methodology | Purpose | Acceptance Criteria(level 2) | Result |
|---|---|---|---|
| Fluid ResistancePerformance ASTM F1862 | The purpose of theperformance testing isto demonstrate thefunctionality of thesubject device. | 29 out of 32 Pass at120 mmHg | 3 lots, 32 out of 32passes at 120 mmHg |
| Particulate FiltrationEfficiency ASTM F2299 | ≥ 98% | 98.69%;99.43%;99.41% | |
| Bacterial FiltrationEfficiency ASTM F2101 | ≥ 98% | 99.89%;99.9%;99.9% | |
| Differential Pressure (DeltaP) EN 14683 Annex C | < 6.0mmH2O/cm² | 2.9mm H2O/cm²; 3.3mmH2O/cm²; 3.3mm H2O/cm² | |
| Flammability 16 CFR 1610 | Class 1 | Class1; Class1;Class1 |
Table 2 - Performance Testing
Table 3 Biocompatibility Comparison
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | The purpose of thetesting is todemonstrate thebiocompatibility ofthe subject device. | Non-Cytotoxic | Under the conditions of thestudy, the device is non-cytotoxic. |
| Irritation | Non-Irritating | Under the conditions of thestudy, the device is non-irritating. | |
| Sensitization | Non-Sensitizing | Under the conditions of thestudy, the device is non-sensitizing |
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K203426 Nantong Taiweishi Medical Technology Co., Ltd. Surgical Face Mask(Non-sterile).
§ 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.