(109 days)
Not Found
No
The 510(k) summary describes a standard medical face mask and its physical characteristics and performance against relevant standards. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device description and intended use focus on protection from transfer of microorganisms, body fluids, and particulate material, which is a barrier function, not a therapeutic treatment of a disease or condition.
No
The device is a medical face mask, intended for infection control and protection from microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.
No
The device described is a physical medical face mask, not a software application. The description focuses on material properties, sizes, and physical characteristics.
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 masks are for protecting against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function.
- Device Description: The description details the physical characteristics of the masks (sizes, ear strap types).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve reagents, analyzers, or test kits.
The device described is a medical face mask, which falls under the category of personal protective equipment (PPE) and is regulated as a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The non-sterile disposable medical 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 face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The proposed device. Disposable medical face masks, is provide in sterile and non-sterile two types.
Both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in five sizes, which are 95mm×155mm, 95mm×140mm, 95mm×145mm and 95mm×160mm. And both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in two ear strap types, Type A, which is ear-loop type, and Type B, which is tie-on type.
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
Operating room personnel and other general healthcare workers.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-7:2018 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
- ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials.(Sterility)
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
- ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
- ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) A of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- Annex C, EN 14683:2019 Medical face masks- Requirements and test methods
- 16 CFR 1610 Standard for the Flammability of Clothing Textiles Corrections
No clinical study is included in this submission.
Key results from performance comparison: The proposed device is Level 2 for fluid resistance, particulate efficiency, bacterial filtration efficiency, and differential pressure, meeting the requirements of ASTM F2100:2019. Biocompatibility tests (cytotoxicity, sensitization, irritation) showed non-cytotoxic, non-sensitizing, and non-irritating results. The device also passed flammability testing (Class 1).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid resistance: Pass at 120mmHg
- Particulate efficiency level: Average 98.17% (non-sterile), Average 98.14% (sterile)
- Bacterial filtration level: Average 98.38% (non-sterile), Average 98.64% (sterile)
- Differential Pressure: Average 1.78 mmH₂O/cm² (non-sterile), Average 1.78 mmH2O/cm² (sterile)
- Flammability: Class 1
- Cytotoxicity: non-cytotoxic
- Sensitization: non-sensitizing
- Irritation: non-irritating
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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 4, 2021
Jiangxi Sanxin Medtec Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China
Re: K202719
Trade/Device Name: Disposable Medical Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 7, 2020 Received: December 11, 2020
Dear Diana Hong:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For CAPT Elizabeth F. Claverie 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) K202719
Device Name Disposable Medical Face Masks
Indications for Use (Describe)
The non-sterile disposable medical 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 face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
× Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K202719
-
- Date of Preparation: 1/1/2021
-
- Sponsor Identification
Jiangxi Sanxin Medtec Co., Ltd.
No.999, Fushan Road, Xiaolan Economic Development, Nanchang, Jiangxi, 330200, China.
Establishment Registration Number: 3005246939
Contact Person: Shuiqing Sun Position: Registered Engineer Tel: +86-791-85988111 Fax: +86-791-85988030 Email: 1304921073@qq.com
- Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Disposable Medical Face Masks Common Name: Surgical Face Mask
Regulatory Information Classification Name: Surgical apparel Class: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital;
Indication for use
The non-sterile disposable medical 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 face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Device Description
The proposed device. Disposable medical face masks, is provide in sterile and non-sterile two types.
Both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in five sizes, which are 95mm×155mm, 95mm×140mm, 95mm×145mm and 95mm×160mm. And both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in two ear strap types, Type A, which is ear-loop type, and Type B, which is tie-on type.
5. Identification of Predicate Devices
Predicate Device 1 510K Number: K153496 Manufacturer: Xiantao Rayxin Medical Products Co., Ltd. Trade Name: Disposable Surgical Face Mask
Predicate Device 2 510K Number: K173062
5
Manufacturer: V&Q Manufacturing Corporation Trade Name: Non Woven Face Mask (Models: VON0185W (earloop) and VON0185B (ties))
-
Non-Clinical Testing 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
ISO 10993-7:2018 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
-
A ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials.(Sterility)
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
-
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
-
A ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
-
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
-
ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
-
ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) A of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
-
Annex C, EN 14683:2019 Medical face masks- Requirements and test methods >
-
16 CFR 1610 Standard for the Flammability of Clothing Textiles Corrections
-
- Clinical Testing
No clinical study is included in this submission.
6
8. Technological Characteristics Comparison
| TEM | Proposed Device | Predicate Device 1
K153496 | Remark |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for Use | The non-sterile disposable medical
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 face
masks are intended for use in
infection control practices to reduce
the potential exposure to blood and
body fluids. This is a single use,
disposable device, provided
non-sterile | The Disposable 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 face
masks are intended for use in
infection control practices to reduce
the potential exposure to blood and
body fluids. This is a single use,
disposable device(s), provided
non-sterile. | Same |
| Mask style | Flat pleated | Flat pleated | Same |
| Design Feature | Ear-loop or tie-on | Ear-loop or tie-on | Same |
| Mask
body
dimension (mm) | 95mm×175mm
95mm×155mm
95mm×140mm
95mm×145mm
95mm×160mm | 175mm×95mm | Different |
| Ties dimension
(mm) | Ear-loop type: 175mm, 160mm,
155mm, 145mm, 140mm
Tie-on type: 277.5mm | Unknown | Different |
| Nose
clip
dimension (mm) | 105mm | Unknown | Different |
| Level | Level 2 | Level 2 | Same |
| Fluid resistance | Pass at 120mmHg | Pass at 120mmHg | Same |
| Particulate
efficiency level | Average 98.17% | 98.46% | Different |
| Bacterial
filtration level | Average 98.38% | 98.7% | Different |
| Differential | Average 1.78 mmH₂O/cm² | 4.2 mmH₂O/cm² | Different |
| Table 1 General comparison for non-sterile disposable medical face masks | ||
|---|---|---|
7
| pressure | |||
|---|---|---|---|
| Flammability | Class 1 | Class 1 | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Single use | Single use | Single use | Same |
| ear strap (ear-loop) | Polyester and spandex | Polyester | |
| ear strap (tie-on) | Polypropylene non-woven fabric | Spun-bond polypropylene | |
| nose clip | Galvanized iron wire coated with polypropylene | Malleable aluminum wire | Different |
| mask body | Polypropylene non-woven fabric and Melt-blown polypropylene | Spun-bond polypropylene | |
| Melt blown polypropylene filter | |||
| Cytotoxicity | Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic. | Under the conditions of the study, not cytotoxicity effect | Same |
| Sensitization | Under the conditions of the study, the proposed device extract was determined to be non-sensitizing. | Under the conditions of the study, not a sensitizer | Same |
| Irritation | Under the conditions of the study, the proposed device extract was determined to be non-irritating. | Under the conditions of the study, not an irritant | Same |
| Sterility | Non-sterile | Non-sterile | Same |
Different - Mask body dimension, Ties dimension and Nose clip dimension
The dimension for the proposed device is different from predicate devices. As the length decreases, the area of the mask decreases gradually. Smaller masks are suitable for patient with smaller face. This difference does not affect intended use and will not raise any safety issues. Therefore, will not affect the safety and effectiveness of the proposed device. Thus, this difference does not affect the substantial equivalence between the proposed device and predicate devices.
Different - Particulate filtration efficiency
The test result for particulate filtration efficiency for the proposed device is different from predicate devices. However, the test result for the proposed device can meet the requirements of level 2 based on ASTM F2100:2019. Therefore, the difference will not affect the safety and effectiveness of the proposed device. Thus, this difference does not affect the substantial equivalence between the proposed device and predicate devices.
Different - Bacterial filtration efficiency
The test result for bacterial filtration efficiency for the proposed device is different from predicate devices. However, the test result for the proposed device can meet the requirements of level 2 based on ASTM F2100:2019. Therefore, the difference will not affect the safety and effectiveness of the proposed
8
device. Thus, this difference does not affect the substantial equivalence between the proposed device and predicate devices.
Different - Differential Pressure
The test result for differential pressure for the proposed device is different from predicate devices. However, the test result for the proposed device can meet the requirements of level 2 based on ASTM F2100:2019. Therefore, the difference will not affect the safety and effectiveness of the proposed device. Thus, this difference does not affect the substantial equivalence between the proposed device and predicate devices.
Different - Patient Contacting Material
The patient contacting material for the proposed device is different from predicate devices. However, biocompatibility test has been conducted on the proposed device and the test result does not show any adverse effect. Therefore, the difference will not affect the safety and effectiveness of the proposed device. Thus, this difference does not affect the substantial equivalence between the proposed device and predicate devices
| ITEM | Proposed Device | Predicate Device 2 | Remark |
|---|---|---|---|
| Product Code | FXX | FXX | Same |
| Regulation | |||
| No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for | |||
| Use | The sterile disposable medical face | ||
| masks are intended for single use by | |||
| operating room personnel and other | |||
| general healthcare workers to protect | |||
| both patients and healthcare workers | |||
| against transfer of microorganisms, | |||
| blood and body fluids, and | |||
| particulate materials. | Non Woven Face Mask (Models: | ||
| VQN0185W (earloop) and | |||
| VQN0185B (ties)) is intended | |||
| for single use by operating room | |||
| personnel and other general | |||
| healthcare workers to protect | |||
| both patients and healthcare | |||
| workers against transfer of | |||
| microorganisms, blood and body | |||
| fluids, and particulate materials. | Same | ||
| Mask style | Flat pleated | Flat pleated | Same |
| Design Feature | Ear-loop or tie-on | Ear-loop or tie-on | Same |
| Dimension | |||
| (mm) | 95mm×175mm | ||
| 95mm×155mm | |||
| 95mm×140mm | |||
| 95mm×145mm | 175mm×95mm | Different | |
| 95mm×160mm | |||
| Ties dimension (mm) | Ear-loop type: 175mm, 160mm, 155mm, 145mm, 140mm | ||
| Tie-on type: 277.5mm | Unknown | ||
| Nose clip dimension (mm) | 105mm | Unknown | |
| Level | Level 2 | Level 2 | Same |
| Fluid resistance | Pass at 120mmHg | Pass at 120mmHg | Same |
| Particulate efficiency level | Average 98.14% | Average 99.74% | Different |
| Bacterial filtration level | Average 98.64% | Average 99.4% | Different |
| Differential pressure | Average 1.78 mmH2O/cm² | Average 2.7mmH2O/cm² | Different |
| Flammability | Class 1 | Class 1 | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Single use | Single use | Single use | Same |
| ear strap (ear-loop) | Polyester and spandex | Urethane elastic fiber or spun-bond polypropylene | Different |
| ear strap (tie-on) | Polypropylene non-woven fabric | ||
| nose clip | Galvanized iron wire coated with polypropylene | White aluminum strip covered by polypropylene covering | |
| mask body | Polypropylene non-woven fabric and Melt-blown polypropylene | Spun-bond polypropylene | |
| Cytotoxicity | Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic. | Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic. | Same |
| Sensitization | Under the conditions of the study, the proposed device extract was determined to be non-sensitizing. | Under the conditions of the study, the proposed device extract was determined to be non-sensitizing. | Same |
| Irritation | Under the conditions of the study, the proposed device extract was determined to be non irritating | Under the conditions of the study, the proposed device extract was determined to be | Same |
| non-irritating. | |||
| Sterility | sterile | non-sterile | Different |
Table 2 General comparison for sterile disposable medical face masks
9
10
Different - Mask body dimension, Ties dimension and Nose clip dimension
The dimension for the proposed device is different from predicate devices. As the length decreases, the area of the mask decreases gradually. Smaller masks are suitable for patient with smaller face. This difference does not affect intended use and will not raise any safety issues. Therefore, the difference will not affect the safety and effectiveness of the proposed device. Thus, this difference does not affect the substantial equivalence between the proposed device and predicate devices.
Different - Particulate filtration efficiency
The test result for particulate filtration efficiency for the proposed device is different from predicate devices. However, the test result for the proposed device can meet the requirements of level 2 based on ASTM F2100:2019. Therefore, the difference will not affect the safety and effectiveness of the proposed device. Thus, this difference does not affect the substantial equivalence between the proposed device and predicate devices.
Different - Bacterial filtration efficiency
The test result for bacterial filtration efficiency for the proposed device is different from predicate devices. However, the test result for the proposed device can meet the requirements of level 2 based on ASTM F2100:2019. Therefore, the difference will not affect the safety and effectiveness of the proposed device. Thus, this difference does not affect the substantial equivalence between the proposed device and predicate devices.
Different - Differential Pressure
The test result for differential pressure for the proposed device is different from predicate devices. However, the test result for the proposed device can meet the requirements of level 2 based on ASTM F2100:2019. Therefore, the difference will not affect the safety and effectiveness of the proposed device. Thus, this difference does not affect the substantial equivalence between the proposed device and predicate devices.
Different - Patient Contacting Material
The patient contacting material for the proposed device is different from predicate devices. However, biocompatibility test has been conducted on the proposed device and the test result does not show any adverse effect. Therefore, the difference will not affect the safety and effectiveness of the proposed device. Thus, this difference does not affect the substantial equivalence between the proposed device and predicate devices.
Different - Product status
The final product status of the proposed device is different from predicate device, one is sterilized and
11
the other is non-sterilized. Sterilization will affect the safety and effective of the mask. The performance testing of the proposed device has been conducted on the final product and the test results show that the proposed sterile mask meets the requirements of ASTM F2100-2019. And biocompatibility testing of the proposed device has also been conducted on the final product and the test results showed that there are no negative impacts from the materials that are used in the proposed sterile mask. Therefore, although the final product status is different between the proposed device and predicate device, the final product status does not affect the safety and effectiveness of the proposed device. Therefore, this difference does not affect the substantial equivalence between the proposed device and predicate device.
9. Conclusions
Based on the comparison and analysis above, the proposed devices are as safe, as effective, and performs as well as the legally marketed predicate devices.