(240 days)
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No
The document describes a standard surgical mask and its performance characteristics based on material properties and filtration efficiency, with no mention of AI or ML.
No
The device is a surgical mask intended for protection and infection control, not for treating or curing a disease or condition.
No
The device is a surgical mask intended for protection against microorganisms and body fluids, not for diagnosing medical conditions.
No
The device description clearly outlines a physical product (masks made of nonwoven polypropylene materials with ear loops or ties and a nose strip) and the performance studies focus on physical properties like fluid resistance, filtration efficiency, and flammability, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting individuals from microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, flammability, biocompatibility). These are not studies related to the accuracy or performance of a diagnostic test.
- Key Metrics: The key metrics measured are related to the physical performance of the mask as a barrier, not diagnostic accuracy metrics like sensitivity, specificity, etc.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This mask does not perform any such function.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
FXX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Non-clinical testing showed:
- ASTM F 1862F/1862M-2017 for Fluid Resistance: Pass at 80 mmHg (Level 1), Pass at 120 mmHg (Level 2), Pass at 160 mmHg (Level 3).
- ASTM F 2299/F2299M-2003(2017) for Particulate Filtration Efficiency: Pass at 98.86% (Level 1), Pass at 98.8% (Level 2), Pass at 98.6% (Level 3).
- ASTM F2101:2019 for Bacteria Filtration Efficiency: Pass at 99.9% for all levels.
- EN14683:2019 +AC2019(E) Annex C for Differential Pressure: Pass at 4.1 mm H2O/cm² (Level 1), Pass at 4.0 mm H2O/cm² (Level 2), Pass at 4.53 mm H2O/cm² (Level 3).
- 16 CFR 1610: 2019 for Flammability: Class 1 for all levels.
- ISO10993-5:2009 for Cytotoxicity: no potential toxicity to L929 cells.
- ISO 10993-10:2010 for Irritation: no potential skin irritation on rabbits in the extraction method.
- ISO 10993-10:2010 for Sensitization: no potential skin sensitization on guinea pigs in the extraction method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of a human figure, and the text is written in blue. The logo is used to identify the FDA, which is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
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
1
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.
2
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
3
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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4
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, 230001 |
| Liu An, Anhui Province | |
| People'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)
5
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.
6
7. Comparison of Technological Characteristics
| Feature | Proposed Device
Surgical Masks
with Ear Loops
or Ties, Level 1,
Level 2, Level 3 | Predicate Device
Surgical Face
Masks Ear Loops
and Tie-on
Level 1, Level 2
and Level 3 | Comparison of
Characteristics
Remarks |
|----------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------|
| 510 (k) No | K202598 | K160269 | - |
| Manufacturer | 3A Medical
Products Co., Ltd | San-M Package
Co. Ltd | - |
| Common Name | Surgical Mask | Surgical Mask | Identical |
| Classification | Class II | Class II | Identical |
| Product Code | FXX | FXX | Identical |
Table B, Comparison of Characteristics
7
| Indications for Use | |||
|---|---|---|---|
| This mask is | |||
| intended to be | |||
| worn to protect | |||
| both the patient | |||
| and healthcare | |||
| worker from the | |||
| transfer 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. | The surgical face | ||
| masks are intended | |||
| to be worn to | |||
| protect both the | |||
| patient and | |||
| healthcare | |||
| personnel from | |||
| transfer of | |||
| microorganisms, | |||
| body fluids and | |||
| particulate | |||
| material. These | |||
| masks are intended | |||
| for use in infection | |||
| control practices to | |||
| reduce the | |||
| potential exposure | |||
| to blood and body | |||
| fluids. This is a | |||
| single-use, | |||
| disposable device | |||
| provided non- | |||
| sterile. | Same |
8
| Outer
| Layer | Polypropylene | Polypropylene | Similar |
|---|---|---|---|
| Please see Note 1 | |||
| Inner Layer | Polypropylene | Polypropylene | Similar |
| Please see Note 1 | |||
| Filter Media | 1. Polypropylene | ||
| Spunbond | |||
| 2.Polypropylene | |||
| Meltblown | 1. Polypropylene | ||
| Spunbond | |||
| 2.Polypropylene | |||
| Meltblown | Similar | ||
| Please see Note 1 | |||
| Nose Strip | Polyethylene | ||
| coated Steel Wire | Polyethylene | ||
| coated Steel Wire | Same | ||
| Ear Loop/Ties | Ear Loops: | ||
| Polyester/Spandex | |||
| Ties: | |||
| Polypropylene | |||
| Spunbond | Ear Loop: | ||
| Polyester, | |||
| Polyurethane | |||
| Ties | |||
| Polypropylene | |||
| Spunbond or | |||
| Polyester | |||
| Spunbond | 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.
9
8. Summary of Non-Clinical Testing
| | Proposed Device
Surgical Masks with Ear
Loops or Ties
Level 1, Level 2, Level 3 | Predicate Device
Surgical Face Masks
Ear Loops and Tie-on
Level 1, Level 2,Level 3 |
|--------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Fluid Resistance | ASTM F 1862F/1862M-
2017 | ASTM F1862 |
| Particulate Filtration
Efficiency | ASTM F 2299/F2299M-
2003(2017) | ASTM F2299 |
| Bacteria Filtration
Efficiency | ASTM F2101:2019 | ASTM F2101 |
| Differential Pressure | EN14683:2019 +AC2019
(E) Annex C | MIL-M36945C |
| Flammability | 16 CFR 1610: 2019 | 16 CFR 1610 |
| Biocompatibility | ISO10993-5:2009
ISO 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 |
10
| | Proposed Device Levels 1, 2 and 3 | | | Predicate Device
Level 1, 2 and 3 | Comparison |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------|
| 16 CFR 1610 | Class 1 | .Class 1 | Class 1 | Class 1 | Same |
| Cytotoxicity ISO
10993-5:2010 | Under the
conditions of
this study the
test article have
no potential
toxicity to L929
cells | Under the
conditions of
this study the
test article have
no potential
toxicity to L929
cells | Under the
conditions of
this study the
test article have
no potential
toxicity to L929
cells | Under the
conditions of the
study the subject
device was non-
cytotoxic. | Similar |
| Irritation
ISO10993-
10:2010 | Under the
experimental
conditions the
test article has
no potential
skin irritation
on rabbits in the
extraction
method. | Under the
experimental
conditions the
test article has
no potential
skin irritation
on rabbits in the
extraction
method. | Under the
experimental
conditions the
test article has
no potential
skin irritation
on rabbits in the
extraction
method. | Under the
conditions of the
study the subject
device was non-
irritating. | Similar |
| Sensitization
ISO 10993-
10:2010 | Under the
experimental
conditions, the
test article has
no potential
skin
sensitization on
guinea pigs in
the extraction
method | Under the
experimental
conditions, the
test article has
no potential
skin
sensitization on
guinea pigs in
the extraction
Method | Under the
experimental
conditions, the
test article has
no potential
skin
sensitization on
guinea pigs in
the extraction
method | Under the
conditions of the
study the subject
device was non-
sensitizing. | Similar |
Table E, Flammability and Biocompatibility Testing Results
11
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.