(272 days)
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
The Disposable Surgical Masks (non-sterile) are 3-ply, ear loop, flat-pleated surgical masks. The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There surgical masks to be secured on users via ear loops made of spandex and nylon. Each mask contains a nose piece to firmly fit over the nose. The devices are sold non-sterile and are intended to be single use and disposable. This device is not made from any natural rubber latex.
This document is a 510(k) summary for a Disposable Surgical Mask (K202580), comparing it to a predicate device (DemeMASK, K201479). The information provided focuses on non-clinical performance testing to demonstrate substantial equivalence, rather than a study involving an AI-powered medical device or human readers.
Therefore, many of the requested details related to AI performance, human reader studies, and expert adjudication are not applicable to this document. The device in question is a physical product (surgical mask), not a diagnostic algorithm or imaging system requiring such analyses.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test | Reported Device Performance (Disposable Surgical Mask) | Acceptance Criteria | Result |
|---|---|---|---|
| Resistance to penetration by synthetic blood (ASTM F1862) | 32 out of 32 passed in 160 mm Hg | 29 out of 32 passed in 160 mm Hg | Pass |
| Sub-micron particulate filtration efficiency at 0.1 micron (ASTM F2299) | ≥99% | ≥98% | Pass |
| Bacterial filtration efficiency (ASTM F2101-19) | ≥99% | ≥98% | Pass |
| Differential pressure (MIL-M-36954) | Average 3.7 mmH₂O/cm² | < 6.0 mmH₂O/cm² | Pass |
| Flame spread (16 CFR 1610) | Class 1 Non-Flammable | Class 1 Non-Flammable | Pass |
2. Sample sizes used for the test set and the data provenance
- Sample Size for Resistance to penetration by synthetic blood: 32 samples were tested.
- Data Provenance: The document does not explicitly state the country of origin of the testing data itself, but the manufacturer is based in China (Qingdao Likangyuan Medical Device Co., Ltd.). The studies are inherently prospective as they are tests performed on manufactured samples to meet regulatory requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical product and the "ground truth" is established through standardized laboratory test methods (e.g., ASTM, MIL-M, ISO standards) rather than expert consensus on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, this involves laboratory testing against established specifications, not human interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device (surgical mask), not an AI-powered diagnostic tool.
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 (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of the surgical mask is defined by industry standards and regulatory requirements (e.g., ASTM, MIL-M, ISO standards) for parameters like fluid resistance, filtration efficiency, and flammability. The device's performance is measured against the specified thresholds in these standards.
8. The sample size for the training set
Not applicable. This is a manufactured product, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
June 7, 2021
Qingdao Likangyuan Medical Device Co., Ltd. % Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302. Building3, Hangqian Mansion, Hangqian Street, Lucheng District Wenzhou, Zhejiang 325000 China
Re: K202580
Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 16, 2021 Received: May 6, 2021
Dear Helen Nan:
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 and Part 809): medical device reporting (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-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,
Bifeng Qian -S
For Clarence W. Murray III, Ph.D. 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
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Indications for Use
510(k) Number (if known) K202580
Device Name Disposable Surgical Mask
Indications for Use (Describe)
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device 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 for K202580
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1.0 Submitter Information
| Company: | Qingdao Likangyuan Medical Device Co., |
|---|---|
| Ltd. | |
| Address: | No.257 Leigongshan Road,Huangdao |
| District,Qingdao,Shandong, 266423, China | |
| Phone: | 086-532-89052813 |
| Contact Name: | Ying Xu |
| Title: | Quality Control Manager |
| E-mail: | likangyuan@hotmail.com |
| Date of Preparation: | June 4, 2021 |
2.0 Submission Correspondent:
| Company: | Wenzhou Cytech Information Service Co., Ltd. |
|---|---|
| Mailing Address: | Room302, Building3, Hangqian Mansion,Hangqian Street, Lucheng District, Wenzhou,Zhejiang, 325000, CHINA |
| Contact Name: | Helen Nan |
| Title: | General Manager |
| Email: | ctc_registration@hotmail.com |
3.0 Subject Device Information
| Trade/Device Name: | Disposable Surgical Mask |
|---|---|
| Model: | Ear-loop Type |
| Common Name: | Surgical Face Mask |
| Regulation Description: | Surgical apparel |
| Device: | Mask, Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Device Class: | Class II |
4.0 Predicate Device Information
| Submitter: | DemeTECH Corporation |
|---|---|
| 510k Number: | K201479 |
| Trade/Device Name: | DemeMASK |
| Common Name: | Surgical Face Mask |
| Regulation Description: | Surgical apparel |
| Device: | Mask, Surgical |
| Review Panel: | General Hospital |
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| Product Code: | FXX |
|---|---|
| Regulation Number: | 21 CFR 878.4040 |
| Device Class: | Class II |
5.0 Device Description
The Disposable Surgical Masks (non-sterile) are 3-ply, ear loop, flat-pleated surgical masks. The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There surgical masks to be secured on users via ear loops made of spandex and nylon. Each mask contains a nose piece to firmly fit over the nose. The devices are sold non-sterile and are intended to be single use and disposable. This device is not made from any natural rubber latex.
6.0 Indications for Use
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
| Device | Predicate Device | Proposed Device | Comparison |
|---|---|---|---|
| Manufacturer | DemeTECH Corporation | Qingdao LikangyuanMedical Device Co., Ltd. | N/A |
| 510K Number | K201479 | K202580 | N/A |
| Trade/DeviceName | DemeMASK | Disposable SurgicalMask (non-sterile) | N/A |
| Product Code | FXX | FXX | Same |
| Classification | Class II(21 CFR 878.4040) | Class II(21 CFR 878.4040) | Same |
| Intended Use | The Disposable SurgicalFace Mask is intended tobe worn to protect boththe patient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids and particulatematerial.This face mask isintended for use ininfection control practices | The Disposable SurgicalMasks (non-sterile) areintended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial.These face masks areintended for use in | Same |
7.0 Comparison of Technological Characteristics
Table 1 - General Comparison
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| to reduce the potentialexposure to blood andbody fluids. This is asingle use, disposabledevice provided non-sterile. | infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable deviceprovided non-sterile. | ||
|---|---|---|---|
| Material | |||
| Outer FacingLayer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Melt Blown | Melt Blown | ||
| Middle Layer | PolypropyleneFilter | PolypropyleneFilter | Same |
| Inner FacingLayer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Nose Piece | Single Galvanize Wire,Coated By PE | Single Galvanize Wire,Coated By PE | Same |
| Mask Style | 3 Ply, Ear Loops, Flat-Pleated Style | 3 Ply, Ear Loops, Flat-Pleated Style | Same |
| Ear loops | Spandex and Nylon | Spandex and Nylon | Same |
| Color | White | Blue (Outer layer)White (Inner layer) | Similar |
| Dimension(Width) | $9.5 cm \pm 1 cm$ | $9.5 cm$ | Similar |
| Dimension(Length) | $17.5 cm \pm 1 cm$ | $17.5 cm$ | Similar |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Shelf life | No Shelf Life | 2 yrs | Different |
| Use | Single Use | Single Use | Same |
| ASTM F2100Level | Level 3 | Level 3 | Same |
| Table 2 - Performance Testing | ||
|---|---|---|
| -- | ------------------------------- | -- |
| Device | Predicate DeviceDemeMASK | Proposed DeviceDisposable SurgicalMask | Comparison |
|---|---|---|---|
| -------- | ------------------------------ | ------------------------------------------------ | ------------ |
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| Fluid ResistancePerformanceASTM F1862 | Pass at 160 mmHg(Level 3 FluidResistance) | Pass at 160 mmHg(Level 3 FluidResistance) | Same |
|---|---|---|---|
| ParticulateFiltrationEfficiencyASTM F2299 | Pass at ≥99% | Pass at ≥99% | Same |
| Bacterial FiltrationEfficiencyASTMF2101 | Pass at ≥99% | Pass at ≥99% | Same |
| DifferentialPressure (Delta P)MIL-M-36954C | Average 3.6mmH2O/cm² | Average 3.7mmH2O/cm² | Similar |
| Flammability16 CFR 1610 | Class 1 | Class 1 | Same |
| BiocompatibilityISO 10993-5 andISO 10993-10 | Under the conditions ofthe studies employed,the device is non-cytotoxic, non-sensitizing, and non-irritating. | Under the conditions ofthe studies employed,the device is non-cytotoxic, non-sensitizing, and non-irritating. | Same |
8.0 Summary of Non-clinical Tests Performed on the Proposed Device
The proposed device was tested and conformed to 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.
Table of Conformity to Standards
| Standards | Name |
|---|---|
| ASTMF1862/F1862M-17 | Standard Test Method for Resistance of Medical Face Masks toPenetration by Synthetic Blood (Horizontal Projection of FixedVolume at a Known Velocity) |
| ASTM F2100-19 | Standard Specification for Performance of Materials Used inMedical Face Masks |
| ASTM F2101-19 | Standard Test Method for Evaluating the Bacterial FiltrationEfficiency (BFE) of Medical Face Mask Materials Using aBiological Aerosol of Staphylococcus aureus |
| MIL-M-36954C | Differential Pressure (Delta-P) |
| ASTMF2299/F2299M-03 | Standard Test Method for Determining the Initial Efficiency ofMaterials Used in Medical Face Masks to Penetration byParticulates Using Latex Spheres |
| 16 CFR PART 1610 | Standard for the flammability of clothing textiles |
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| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity |
|---|---|
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests forIrritation and skin sensitization |
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| Standards | Disposable SurgicalMaskEar Loop | Acceptance Criteria | Result |
|---|---|---|---|
| Resistance topenetration bysynthetic bloodASTM F1862 | 32 out of 32 passed in160 mm Hg | 29 out of 32 passed in160 mm Hg | Pass |
| Sub-micronparticulate filtrationefficiency at0.1 micronASTM F2299 | ≥99% | ≥98% | Pass |
| Bacterial filtrationefficiencyASTM F2101-19 | ≥99% | ≥98% | Pass |
| Differential pressureMIL-M-36954 | Average 3.7mmH₂O/cm² | < 6.0mmH₂O/cm² | Pass |
| Flame spread16 CFR 1610 | Class 1Non-Flammable | Class 1Non-Flammable | Pass |
9.0 Table of BiocompatibilityTesting
| Standards | Proposed Device | Result |
|---|---|---|
| CytotoxicityISO 10993-5 | Under the conditions of the study, the device is non-cytotoxic. | Pass |
| Skin Sensitization TestISO 10993-10 | Under the conditions of the study, the device is non-sensitizing. | Pass |
| Skin Irritation TestISO 10993-10 | Under the conditions of the study, the device is non-irritating. | Pass |
9.0 Summary of Clinical Performance Test
No clinical study is included in this submission.
10.0 Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202580, the Disposable Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared underK201479.
§ 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.