(169 days)
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
The surgical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spun-bond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.
This document pertains to the 510(k) premarket notification for a Disposable Surgical Mask (K203756). The study described focuses on the device's functional performance and biocompatibility rather than human-in-the-loop performance with an AI. Therefore, the questions related to AI assistance, human reader improvement, multi-reader multi-case studies, and ground truth establishment from expert consensus for AI training are not applicable to the context of this traditional medical device submission.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the device's performance evaluation is found in the "Summary of Non-clinical Testing" section, specifically in the table on page 8.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | To evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of high-velocity stream of synthetic blood. Pass/fail determinations are based on visual detection of synthetic blood penetration. | 29 Out of 32 pass at 160 mmHg | Lot 1: 32 Out of 32 pass at 160 mmHgLot 2: 32 Out of 32 pass at 160 mmHgLot 3: 32 Out of 32 pass at 160 mmHgResult: Pass |
| Particulate Filtration Efficiency (ASTM F2299) | To measure the initial particulate filtration efficiency of materials using monodispersed aerosols containing suspended latex spheres particulates of 0.1μm diameter. | ≥ 98% | Lot 1: 99.8%Lot 2: 99.9%Lot 3: 99.9%Result: Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | To determine the bacterial filtration efficiency of the mask. | ≥ 98% | Lot 1: > 99.9%Lot 2: > 99.9%Lot 3: > 99.9%Result: Pass |
| Differential Pressure (EN 14683:2019) | To measure the differential pressure between the inside and outside of the mask. | < 6.0 mmH2O/cm² | Lot 1: 3.4 mmH2O/cm²Lot 2: 3.5 mmH2O/cm²Lot 3: 3.3 mmH2O/cm²Result: Pass |
| Flammability (16 CFR 1610) | To determine the flammability characteristics of the mask. Materials shall meet requirements for Class 1 (normal flammability). | Class 1 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1Result: Pass |
| Cytotoxicity (ISO 10993-5) | To determine the biological reactivity of a mammalian cell culture (mouse fibroblast L929 cells) in response to the test article. | Non-Cytotoxic | Under the conditions of the study, non-cytotoxicity effect |
| Irritation (ISO 10993-10) | To evaluate the potential skin irritation caused by the extraction of the test article extract contacting with the skin surface of rabbits. | Non-Irritating | Under the conditions of the study, non-irritation |
| Sensitization (ISO 10993-10) | To evaluate the potential of test article extracts to cause skin sensitization in the guinea pig according to GPMT method. | Non-Sensitizing | Under the conditions of the study, non-sensitization |
2. Sample Size Used for the Test Set and Data Provenance
For the performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability), results are reported for 3 lots of the disposable surgical mask. Specific sample sizes within each lot for individual tests are provided where applicable (e.g., 32 out of 32 for Fluid Resistance).
The data provenance is from non-clinical testing, likely conducted by the manufacturer or a contracted lab in China, given the manufacturer's location (Yixing, Jiangsu, China). The data is by nature prospective, as it was generated specifically for this 510(k) submission to demonstrate compliance with performance and biocompatibility standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission is for a traditional medical device (surgical mask), not an AI device requiring ground truth established by expert medical reviewers. The "ground truth" for the device's performance is established by standardized, objective laboratory test methods (e.g., ASTM, EN, ISO standards), which measure physical and biological properties.
4. Adjudication Method for the Test Set
Not applicable. As the "ground truth" is based on objective laboratory measurements according to established standards, there is no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a submission for a physical medical device (surgical mask), not an AI-assisted diagnostic or treatment system. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission is for a non-AI physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this medical device is based on objective, quantitative measurements performed according to recognized international and national standards. This includes:
- Physical Performance Data: Measured values for fluid resistance, particulate filtration efficiency, bacterial filtration efficiency, differential pressure, and flammability.
- Biocompatibility Data: Results from in vitro cytotoxicity tests and in vivo irritation and sensitization tests (using animal models, specifically rabbits and guinea pigs).
These standards define the acceptable range or threshold for each performance characteristic, effectively serving as the "ground truth" for the device's safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense. The device's performance is based on its physical design and materials, which are verified through the non-clinical tests described.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it is irrelevant to this submission.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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.
June 10, 2021
Lucky Textile Industrial(Wuxi) Co.,Ltd. Grace Tai General Manager Assistant No.10 Zhuqiao Road, Yixing Economic and Technological Development Zone , Yixing, Jiangsu, China Yixing, Jiangsu 214200 China
Re: K203756
Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 8, 2021 Received: May 13, 2021
Dear Grace Tai:
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
{1}------------------------------------------------
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K203756
Device Name Disposable Surgical Mask
Indications for Use (Describe)
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Registration Use (Part 21 CFR 601 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 601 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
510(k) Number: K203756 Date Prepared: June 10,2021
1.Submission Sponsor
| Manufacturer information | |
|---|---|
| Company: Lucky Textile Industrial(Wuxi) Co.,Ltd. | |
| Company address: No.10 Zhuqiao Road, YixingEconomic and Technological DevelopmentZone, Yixing, Jiangsu, China. | |
| Contact person: Grace Tai | |
| Phone: +86-510-80192890 | |
| Fax: / | |
| E-mail: lqsy@luckytextiles.cn |
2. Submission correspondent
| Name | Lucky Textile Industrial(Wuxi) Co.,Ltd. |
|---|---|
| Address/Post Code | No.10 Zhuqiao Road, Yixing Economic andTechnological Development Zone , Yixing, Jiangsu, China. |
| Phone No. | +86-510-80192890 |
| Contact Person | Grace Tai |
| lqsy@luckytextiles.cn |
3. Device Identification
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Disposable Surgical Mask |
| Model: | |
| Classification name: | Mask, Surgical |
| Review Panel: | Surgical Apparel |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 21 CFR 878.4040 |
{4}------------------------------------------------
4. Legally Marketed Predicate Device
| Trade Name | Surgical face mask |
|---|---|
| Regulation number | 21 CFR 878.4040 |
| Regulation class | II |
| Regulation name | Surgical face mask |
| 510(k) Number | K203756 |
| Product Code | FXX |
| Manufacturer | Lucky Textile Industrial(Wuxi) Co.,Ltd. |
5. Device Description
The surgical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spun-bond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.
6. Intended Use/ Indications for Use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
7. Technological characteristics comparison
| Comparisonitem | Subject Device: DisposableSurgical Mask(K203756) | Predicate Device: Single-use Surgical Mask(K200847) | Comments |
|---|---|---|---|
| ProductCode | FXX | FXX | Same |
| RegulationNumber | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classification | Class II | Class II | Same |
| Use(OTC/RX) | OTC | OTC | Same |
| IntendedUse & | When properly worn, thesurgical face masks areintended to protect bothpatient and healthcareworkers from transfer ofmicroorganisms, body fluidsand particulate materials.This device is non sterile andfor single use only. | When properly worn, thesurgical face masks areintended to protect bothpatient and healthcareworkers from transfer ofmicroorganisms, bodyfluids and airborneparticles. This device isnon-sterile and forsingle use only. | Same |
| Comparisonitem | Subject Device: DisposableSurgical Mask (K203756) | Predicate Device: Single-use Surgical Mask(K200847) | Comments |
| Indicationsfor Use | When properly worn, the surgical face masks areintended to protect both patient and healthcareworkers from transfer of microorganisms, bodyfluids and particulate materials. This device isnon sterile and for single use only. | When properly worn, the surgical face masks areintended to protect both patient and healthcareworkers from transfer of microorganisms, bodyfluids and airborne particles. This device isnon-sterile and for single use only. | |
| Designfeature | 3 Ply, Ear Loops,Flat-Pleated Style | 3 Ply, Ear Loops, Flat-Pleated Style | Same |
| Usage | Single use | Single use | Same |
| Color | Blue | White | DifferentIssue 1Similar |
| Size | $9.5cm \pm 0.5cm$ (Width)$17.5cm \pm 0.5cm$ (Length) | $9.0cm \pm 0.5cm$ (Width)$17.5cm \pm 0.5cm$ (Length) | Issue 2 |
| SterilizationStatus | Non-sterile | Non-sterile | Same |
| Material | Outer layer:Spun-bond polypropylene | Outer layer:Spun-bond polypropylene | Same |
| Middle layer:Melt blown polypropylenefilter | Middle layer:Melt blown polypropylenefilter | Same | |
| Inner layer:Spun-bond polypropylene | Inner layer:Spun-bond polypropylene | Same | |
| Nose piece:Single GalvanizeWire, Coated By PE | Nose piece:Single Galvanize Wire,Coated By PE | Same | |
| Comparisonitem | Subject Device: DisposableSurgical Mask(K203756) | Predicate Device: Single-use Surgical Mask(K200847) | Comments |
| Ear-Piece: Spandex | Ear-Piece: not made withnatural rubber latex | Same | |
| ASTM F2100 Level | Level 3 | Level 2 | Issue 3 |
| FluidResistancePerformanceASTM F1862-13 | Lot 1: 32 Out of 32 pass at 160mmHgLot 2: 32 Out of 32 pass at 160mmHgLot 3: 32 Out of 32 pass at 160mmHg | 30 Out of 32 pass at 120mmHg | DifferentIssue 4 |
| ParticulateFiltrationEfficiencyASTM F2299 | Lot 1:99.8%Lot 2:99.9%Lot 3: 99.9% | 99.9% | Same |
| BacterialFiltrationEfficiencyASTM F2101 | Lot 1: > 99.9%Lot 2: > 99.9%Lot 3: > 99.9% | > 99.9% | Same |
| DifferentialPressure(Delta P) EN14683:2019+AC : 2019 | Lot 1: 3.4 mmH20/cm²Lot 2: 3.5 mmH20/cm²Lot 3: 3.3 mmH20/cm² | 3.0 mmH20/cm² | Same |
| Flammability16CFR 1610 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 | Class 1 | Same |
| Cytotoxicity | Comply with ISO 10993-5Non cytotoxic | Comply with ISO 10993-5Non cytotoxic | Same |
| Irritation | Comply with ISO 10993-10Non irritating | Comply with ISO 10993-10Non irritating | Same |
| Sensitization | Comply with ISO 10993-10Non sensitizing | Comply with ISO 10993-10Non sensitizing | Same |
{5}------------------------------------------------
{6}------------------------------------------------
Discuss of Comments:
{7}------------------------------------------------
lssue 1: The composition of colorants are Phthalocyanine Blue BGS (CAS No.147-14-8) and Pigment Violet 23 (CAS No. 6358-30-1), we provided the MSDS of color additive used in our manufacturing process.
lssue 2: The width dimension of subject is a little longer than that of predicate device, this difference does not affect the safety and effectiveness.
lssue 3: Subject device comply with ASTM F 2100 Level 3, and we have done corresponding performance tests.
lssue 4:The test result of Fluid Resistance Performance meets the requirement of ASTM F 2100 Level 3.
8. Summary of Non-clinical Testing
Non-clinical tests were conducted and conformed to the following standards and the requirements state in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 05, 2004.
Standards: List as Applicable
- ASTM F2100-19 Standard Specification For Performance of Materials used in Medical Face Masks.
- ASTM F1862-13 Standard Test Method For Resistance of Medical Face Masks to Penetration by Synthetic Blood.
- ASTM F2299-03 Stand Test Method For Determining The Initial Efficiency Of Materials Used In Medical Face Masks To Penetration By Particulates Using Latex Spheres.
- ASTM F 2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- 16 CFR 1610 Standard For The Flammability Of Clothing Textiles.
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices Part 5: ● Tests For In Vitro Cytotoxicity.
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices – Part 10: Tests For Irritation And Skin Sensitization.
{8}------------------------------------------------
| Test Methodology | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|
| Fluid ResistancePerformance(ASTM F1862) | The test method is used toevaluate the resistance ofmedical face masks topenetration by the impact of asmall volume(~2 mL) of high-velocity stream of syntheticblood. The pass/faildeterminations are based onvisual detection of syntheticblood penetration. | 29 Out of 32 pass at160 mmHg | Lot 1: 32 Out of 32pass at 160 mmHgLot 2: 32 Out of 32pass at 160 mmHgLot 3: 32 Out of 32pass at 160 mmHgPass |
| Particulate FiltrationEfficiency(ASTM F2299) | The purpose of this testmethod is to measure the initialpartical filtration efficiency ofmaterials using monodispersedaerosols containing suspendedlatex spheres particulates of0.1μm diameter. | ≥ 98% | Lot 1:99.8%Lot 2:99.9%Lot 3: 99.9%Pass |
| Bacterial FiltrationEfficiency(ASTM F2101) | The purpose of this testmethod is to determine thebacterial filtration efficiency ofthe mask as specified in ASTMF2101. | ≥ 98% | Lot 1: > 99.9%Lot 2: > 99.9%Lot 3: > 99.9%Pass |
| Differential Pressure(EN 14683:2019) | The purpose of this test s tomeasure the differentialpressure between the insideand outside of the mask. | < 6.0 mmH20/cm² | Lot 1: 3.4 mmH20/cm²Lot 2: 3.5 mmH20/cm²Lot 3: 3.3 mmH20/cm²Pass |
| Flammability(16 CFR 1610) | The purpose of this testmethod is to determine theflammability charateristics ofthe mask as specified in 16CFR Part 1610. Materials inthe construction of medicalface masks shall meet therequirements for Class 1,normal flammability specified in16 CFR Part 1610. | Class 1 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1Pass |
| Table 2: Performance Characteristic Comparison | ||
|---|---|---|
| ------------------------------------------------ | -- | -- |
{9}------------------------------------------------
| TestMethodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Cytotoxicity | The purpose of thetest is to determinethe biological reactivityof a mammalian cellculture (mousefibroblast L929cells) inresponse to the testarticle. | Non-Cytotoxic | Under the conditions ofthe study, non-cytotoxicityeffect |
| Irritation | To evaluate the potentialskin irritation caused bythe extraction of the testarticle extract contactingwith the skin surface ofrabbits. | NonSensitizing | Under the conditions of thestudy, non-irritation |
| Sensitization | To evaluate the potentialof test article extracts tocause skin sensitizationin the guinea pigaccording to GPMTmethod. | Non-Irritating | Under the conditions of thestudy, non-sensitization |
Table 3: Biocompatibility Comparison
9. Brief discussion of clinical tests
No clinical tests were performed, or discuss as applicable.
10. Conclusions
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission K203756, the Disposable Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K200847.
§ 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.