(240 days)
This mask is intended to be worn to protect both the patient and healthcare worker of microorganisms, body fluids and particulate material. This mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use device provided non-sterile
These 3 Layer Surgical Masks: Level 1, Level 2 or Level 3 (with Ear Loops or Ties) are 3 layer, flat-folded masks constructed of 100% nonwoven polypropylene materials. The masks are provided with Ear Loops (Polyester/Spandex) or Ties (Polypropylene). A malleable nose strip is placed within the binding for comfort and individualized fit. These masks meet the acceptance criteria for ASTM F 2100, Level 1, Level 2 or Level 3 performance standards and are provided in blue. These masks are single use and provided non-sterile.
This document is a 510(k) Premarket Notification for 3A Medical Products Co., Ltd.'s 3 Layer Surgical Masks, seeking substantial equivalence to a predicate device. It details the masks' performance characteristics against recognized consensus standards for surgical masks.
-
A table of acceptance criteria and the reported device performance:
Test Methods Acceptance Criteria for Proposed Device Levels Reported Device Performance (Proposed Device) Predicate Device Performance Comparison ASTM F2100 (Performance Standard) N/A (Categorizes into levels 1, 2, 3) Level 1, Level 2, Level 3 Level 1, Level 2, Level 3 Same ASTM F1862 (Fluid Resistance) Pass at 80 mmHg (Level 1) Pass at 80 mmHg Pass at 80 mmHg Same Pass at 120 mmHg (Level 2) Pass at 120 mmHg Pass at 120 mmHg Same Pass at 160 mmHg (Level 3) Pass at 160 mmHg Pass at 160 mmHg Same ASTM F2299 (Particulate Filtration Efficiency) N/A (Measured for comparison against predicate) Pass at 98.86% (Level 1) Pass at 99.6% Similar Pass at 98.8% (Level 2) Pass at 99.6% Similar Pass at 98.6% (Level 3) Pass at 99.7% Similar ASTM F2101 (Bacteria Filtration Efficiency) N/A (Measured for comparison against predicate) Pass at 99.9% (Level 1) Pass at >98% Similar Pass at 99.9% (Level 2) Pass at >98% Similar Pass at 99.9% (Level 3) Pass at >99% Similar EN14683 (Proposed) / MIL-M36945C (Predicate) (Differential Pressure) N/A (Measured for comparison against predicate) Pass at 4.1 mm H2O/cm² (Level 1) Pass at 2.0mm H2O/cm² Similar Pass at 4.0 mm H2O/cm² (Level 2) Pass at 1.6mm H2O/cm² Similar Pass at 4.53 mm H2O/cm² (Level 3) Pass at 2.5mm H2O/cm² Similar 16 CFR 1610 (Flammability) Class 1 Class 1 (all levels) Class 1 Same ISO 10993-5:2010 (Cytotoxicity) Non-toxic potential to L929 cells No potential toxicity to L929 cells (all levels) Non-cytotoxic Similar ISO 10993-10:2010 (Irritation) No potential skin irritation on rabbits No potential skin irritation on rabbits (all levels) Non-irritating Similar ISO 10993-10:2010 (Sensitization) No potential skin sensitization on guinea pigs No potential skin sensitization on guinea pigs (all levels) Non-sensitizing Similar -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes used for each specific test (e.g., number of masks tested for fluid resistance). The data provenance is derived from tests conducted to demonstrate conformance to recognized consensus standards like ASTM and ISO. The manufacturer, 3A Medical Products Co., Ltd., is located in Liu An, Anhui Province, People's Republic of China, suggesting the testing was likely conducted in or for China on a prospective basis for market clearance. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This document describes testing against performance standards for medical devices, not an algorithm that requires expert ground truth establishment. The "ground truth" here is defined by the objective, quantifiable metrics set forth in recognized international standards (e.g., ASTM, ISO). Therefore, no human experts for establishing ground truth are applicable in this context. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used for subjective interpretations or diagnostic accuracy studies, not for objective physical and biological performance testing of a medical device like a surgical mask against established standards. -
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 submission for a physical medical device (surgical masks), not an AI-powered diagnostic or assistive tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document pertains to a physical medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance of these surgical masks is established by the objective, quantitative results of standardized laboratory tests against recognized consensus standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, EN14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define specific methodologies and thresholds that a device must meet to achieve a certain performance level. -
The sample size for the training set:
Not applicable. This document relates to a physical medical device and its performance testing, not a machine learning model that requires a training set. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for a physical medical device.
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March 3, 2022
3A Medical Products Co., Ltd Mary Mejaes Consultant Yu An Industrial Park 230001 Liu An, Anhui China
Re: K202598
Trade/Device Name: 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel
Regulatory Class: Class II Product Code: FXX
Dear Mary Mejaes:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 6, 2021. Specifically, FDA is updating this SE Letter for a missing trade name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Clarence W. Murray III, PhD., OHT4: Office of Surgical and Infection Control Devices, 301-796-0270, clarence.murray@fda.hhs.gov.
Sincerely,
Liqun Zhao -S
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 Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Underneath the square, the words "U.S. Food & Drug Administration" are written in blue.
May 6, 2021
3A Medical Products Co., Ltd Marv Meiaes Consultant Yu An Industrial Park 230001 Liu An, Anhui China
Re: K202598
Trade/Device Name: 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3
Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 20, 2021 Received: March 1, 2021
Dear Mary Mejaes:
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 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ryan Ortega -S
Ryan Ortega, 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
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Indications for Use
510(k) Number (if known) K202598
Device Name
3 Layer Surgical Mask with Ear Loops, Level 1 3 Layer Surgical Mask with Ear Loops, Level 2 3 Layer Surgical Mask with Ear Loops, Level 3
3 Layer Surgical Mask with Ties, Level 1 3 Layer Surgical Mask with Ties, Level 2 3 Layer Surgical Mask with Ties, Level 3
Indications for Use (Describe)
This mask is intended to be worn to protect both the patient and healthcare worker of microorganisms, body fluids and particulate material. This mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use 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
Date of Summary Preparation: April 29, 2021 Type of 510K: Traditional 510K Number: K202598
| 1. Applicant: | 3A Medical Products Co., Ltd. |
|---|---|
| Address: | Yu An Industrial Park, 230001Liu An, Anhui ProvincePeople's Republic of China |
| Tel No. | 86-564-3611700 |
| Fax No. | 86-5643611700 |
| Email Address: | info@3a-medical.cn |
| Consultant: | Mary Mejaes |
2. Proprietary Device Name
- 3 Layer Surgical Mask with Ear Loops: Level 1 Level 1 3 Layer Surgical Mask with Ties: 3 Layer Surgical Masks with Ear Loops: Level 2 3 Layer Surgical Masks with Ties: Level 2 3 Layer Surgical Masks with Ear Loops: Level 3 3 Layer Surgical Masks with Ties: Level 3
Regulatory Information: 3.
Classification Name: Surgical Face Masks/Apparel Classification: Class II Product Code: FXX Regulation No. 21 CFR 878.4040
4. Predicate Device:
510K Number: K160269 Manufacturer: SAN-M Package Co., Ltd. Device Name: Surgical Face Masks (Ear Loops and Tie On)
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5. Indications for Use/Intended Use:
This mask is intended to be worn to protect both the patient and healthcare worker from transfer of microorganisms, body fluid and particulate material. This mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use device and is provided non-sterile.
6. Device Description:
These 3 Layer Surgical Masks: Level 1, Level 2 or Level 3 (with Ear Loops or Ties) are 3 layer, flat-folded masks constructed of 100% nonwoven polypropylene materials. The masks are provided with Ear Loops (Polyester/Spandex) or Ties (Polypropylene). A malleable nose strip is placed within the binding for comfort and individualized fit. These masks meet the acceptance criteria for ASTM F 2100, Level 1, Level 2 or Level 3 performance standards and are provided in blue. These masks are single use and provided non-sterile.
3 Layer Surgical Masks Model Numbers
| Barrier Levels | Ear Loops | Ties |
|---|---|---|
| Level 1 | Ref: 1000E | Ref: 1000T |
| Level 2 | Ref: 2000E | Ref: 2000T |
| Level 3 | Ref: 3000E | Ref: 3000T |
Table A, Model Nos.
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7. Comparison of Technological Characteristics
| Feature | Proposed DeviceSurgical Maskswith Ear Loopsor Ties, Level 1,Level 2, Level 3 | Predicate DeviceSurgical FaceMasks Ear Loopsand Tie-onLevel 1, Level 2and Level 3 | Comparison ofCharacteristicsRemarks |
|---|---|---|---|
| 510 (k) No | K202598 | K160269 | - |
| Manufacturer | 3A MedicalProducts Co., Ltd | San-M PackageCo. Ltd | - |
| Common Name | Surgical Mask | Surgical Mask | Identical |
| Classification | Class II | Class II | Identical |
| Product Code | FXX | FXX | Identical |
Table B, Comparison of Characteristics
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| Indications for Use | |||
|---|---|---|---|
| This mask isintended to beworn to protectboth the patientand healthcareworker from thetransfer ofmicroorganisms,body fluids andparticulatematerial. Thismask is intendedfor use in infectioncontrol practices toreduce thepotential exposureto blood and bodyfluids. This is asingle use deviceprovided non-sterile. | The surgical facemasks are intendedto be worn toprotect both thepatient andhealthcarepersonnel fromtransfer ofmicroorganisms,body fluids andparticulatematerial. Thesemasks are intendedfor use in infectioncontrol practices toreduce thepotential exposureto blood and bodyfluids. This is asingle-use,disposable deviceprovided non-sterile. | Same |
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| OuterLayer | Polypropylene | Polypropylene | Similar |
|---|---|---|---|
| Please see Note 1 | |||
| Inner Layer | Polypropylene | Polypropylene | Similar |
| Please see Note 1 | |||
| Filter Media | 1. PolypropyleneSpunbond2.PolypropyleneMeltblown | 1. PolypropyleneSpunbond2.PolypropyleneMeltblown | SimilarPlease see Note 1 |
| Nose Strip | Polyethylenecoated Steel Wire | Polyethylenecoated Steel Wire | Same |
| Ear Loop/Ties | Ear Loops:Polyester/SpandexTies:PolypropyleneSpunbond | Ear Loop:Polyester,PolyurethaneTiesPolypropyleneSpunbond orPolyesterSpunbond | Similar |
| Color | Blue | White or Blue | Similar |
| Dimensions | $9.5\pm1cm$x $17.5 cm \pm1$cm | $95 \pm3mm$ x$175\pm5mm$ ,$90\pm3mm$ x 180mm | Similar |
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
Note 1: The outer layer, inner layer and filter media of the proposed devices have the same material content but with different weights in order to meet the safety and effectiveness of each barrier level. They still meet the requirements of essential performance standard ISO 10993.
The proposed device under this premarket notification submission 510(k) K202598 is the same or similar in design, indications for use, technological characteristic and is composed of the same or similar components as the predicate device 510(k) K160269.
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8. Summary of Non-Clinical Testing
| Proposed DeviceSurgical Masks with EarLoops or TiesLevel 1, Level 2, Level 3 | Predicate DeviceSurgical Face MasksEar Loops and Tie-onLevel 1, Level 2,Level 3 | |
|---|---|---|
| Fluid Resistance | ASTM F 1862F/1862M-2017 | ASTM F1862 |
| Particulate FiltrationEfficiency | ASTM F 2299/F2299M-2003(2017) | ASTM F2299 |
| Bacteria FiltrationEfficiency | ASTM F2101:2019 | ASTM F2101 |
| Differential Pressure | EN14683:2019 +AC2019(E) Annex C | MIL-M36945C |
| Flammability | 16 CFR 1610: 2019 | 16 CFR 1610 |
| Biocompatibility | ISO10993-5:2009ISO 10993-10:201 | ISO 10993 |
Table C, Test Methods Used
Table D, Performance Testing
| Test Methods | Proposed Device Surgical Masks (Ear Loops or Ties) | Predicate Device Level 1 | Predicate Device Level 2 | Predicate Device Level 3 | Comparison | ||
|---|---|---|---|---|---|---|---|
| ASTM F2100 | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Same |
| ASTM F1862 | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Same |
| ASTM 2299 | Pass at 98.86% | Pass at 98.8% | Pass at 98.6% | Pass at 99.6% | Pass at 99.6% | Pass at 99.7% | Similar |
| ASTM F2101 | Pass at 99.9% | Pass at 99.9% | Pass at 99.9% | Pass at >98% | Pass at >98% | Pass at >99% | Similar |
| EN14683 for proposed and Mil-M26945C for the predicate | Pass at 4.1 mm H2O/cm² | Pass at 4.0 mm H2O/cm² | Pass at 4.53 mm H2O/cm² | Pass at 2.0mm H2O/cm² | Pass at 1.6mm H2O/cm² | Pass at 2.5mm H2O/cm² | Similar |
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| Proposed Device Levels 1, 2 and 3 | Predicate DeviceLevel 1, 2 and 3 | Comparison | |||
|---|---|---|---|---|---|
| 16 CFR 1610 | Class 1 | .Class 1 | Class 1 | Class 1 | Same |
| Cytotoxicity ISO10993-5:2010 | Under theconditions ofthis study thetest article haveno potentialtoxicity to L929cells | Under theconditions ofthis study thetest article haveno potentialtoxicity to L929cells | Under theconditions ofthis study thetest article haveno potentialtoxicity to L929cells | Under theconditions of thestudy the subjectdevice was non-cytotoxic. | Similar |
| IrritationISO10993-10:2010 | Under theexperimentalconditions thetest article hasno potentialskin irritationon rabbits in theextractionmethod. | Under theexperimentalconditions thetest article hasno potentialskin irritationon rabbits in theextractionmethod. | Under theexperimentalconditions thetest article hasno potentialskin irritationon rabbits in theextractionmethod. | Under theconditions of thestudy the subjectdevice was non-irritating. | Similar |
| SensitizationISO 10993-10:2010 | Under theexperimentalconditions, thetest article hasno potentialskinsensitization onguinea pigs inthe extractionmethod | Under theexperimentalconditions, thetest article hasno potentialskinsensitization onguinea pigs inthe extractionMethod | Under theexperimentalconditions, thetest article hasno potentialskinsensitization onguinea pigs inthe extractionmethod | Under theconditions of thestudy the subjectdevice was non-sensitizing. | Similar |
Table E, Flammability and Biocompatibility Testing Results
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The proposed models under this premarket notification submission have similar performance characteristics and conform to the same Recognized Consensus Standards. These standards include testing that covers Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Fluid Resistance, Flammability, Differential Pressure (Breathability) and Biocompatibility. Differences between the Proposed 3 Layer Surgical Masks (Ear Loop and Tie on) and the predicate devices did not raise any new concerns regarding safety and effectiveness. Both meet the Recognized Consensus Standards acceptance criteria.
9. Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject device in 510(k) submission K202598, 3 Layer Surgical Masks with Ear Loops or Ties, Level 1, Level 2, and Level 3 is as safe and effective and performs as well or better than the legally marketed predicate device cleared under 510(k) K160269.
§ 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.