(35 days)
Not Found
No
The device description and performance studies focus solely on the physical barrier properties and material characteristics of surgical face masks. There is no mention of any computational or data-driven components that would suggest the use of AI or ML.
No
The device is a surgical face mask intended to protect against transfer of microorganisms and body fluids by acting as a physical barrier, which is a preventive rather than a therapeutic function.
No
The device description clearly states its function as providing a physical barrier to protect against the transfer of microorganisms and body fluids. There is no mention of it being used to diagnose or detect medical conditions or diseases.
No
The device description clearly describes a physical surgical face mask made of materials like melt-blown layers and PET coated iron wire, which are hardware components. The performance studies also focus on physical properties like fluid resistance and filtration efficiency, not software metrics.
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 both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and function of the mask as a barrier.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the physical barrier properties (fluid resistance, filtration efficiency, breathability) and safety (flammability, biocompatibility), which are relevant to a protective device, not a diagnostic one.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not fit that definition.
N/A
Intended Use / Indications for Use
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 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.
Level 2 Face Mask Models: # FCY-L2-E, FCY-L2-T
Level 3 Face Mask Models: # FCY-L3-E, FCY-L3-T
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Proposed device has one size 17.5 cm x 9.5 cm and two wear types of Ear Loops and Tie-On. They are available in blue and white colors and three barrier levels (Level 3) according to ASTM F2100:2019.
The proposed Level 2 and Level 3 masks are the same product which can pass ASTM F2100-19 Level 2 / 2 & 3 at the same time; they are classified into level 3 just because of the marketing strategies. All the materials of proposed tie-on masks are included in ear loops masks. The outer layer, inner layer, middle melt-blown layer and PET coated iron wire nose clip of tie-on masks are exactly the same with ear-loop masks, the tie tapes of tie-on masks are same as the outer layer of white mask body but 3 layers folded and physically ultrasonic welding together.
The proposed mask can form a physical barrier by being worn on the mouth and nose of medical staff to protect both the patient and healthcare personnel from the spread of microorganisms, blood and body fluids, and particulate materials.
The proposed subject device, surgical face mask, operates by acting as a physical barrier. The barrier protects the medical staff, patient, and healthcare personnel from the spread of microorganisms, blood and body fluids, and particulate materials. The barrier goes over the mouth and nose of the user.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Conclusion: The test results demonstrated that the proposed devices are in compliance with the following standards:
- 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) [FR Recognition #6-406]
- 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 F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus [FR Recognition #6-427]
- 16 CFR 1610 Standard for the Flammability of Clothing Textiles Corrections
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks [FR Recognition #6-425]
- EN 14683:2019+AC: 2019 Annex C Medical face masks. Requirements and test methods
- ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity [FR Recognition #2-245]
- ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization.[FR Recognition #2-174]
Clinical Test Conclusion: No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cytotoxicity: No Cytotoxicity
Sensitization: No Sensitization
Irritation: No Irritation
Sterility: Non-Sterile
For Level 2:
Fluid resistance: Pass at 120mmHg
Particulate efficiency level: Pass at 99.5%
Bacterial filtration level: Pass at 99.9%
Differential pressure: Pass at 3.6mmH2O/cm²
Flammability: Class 1
For Level 3:
Fluid resistance: Pass at 160mmHg
Particulate efficiency level: Pass at 99.5%
Bacterial filtration level: Pass at 99.9%
Differential pressure: Pass at 3.6mmH2O/cm²
Flammability: Class 1
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 the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
March 4, 2021
Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K210225
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 27, 2021 Received: January 28, 2021
Dear Prithul Bom:
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.
1
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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K210225
Device Name
Surgical Face Mask (Ear loops and Tie-on)
Indications for Use (Describe)
The surgical face masks are intended to be worn to protect 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.
Level 2 Face Mask Models: # FCY-L2-E, FCY-L2-T Level 3 Face Mask Models: # FCY-L3-E, FCY-L3-T
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number:
-
- Date of Preparation: 3/2/2021
-
- Sponsor Identification
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO., LTD
Room. 1304, Technology Innovation Park, Shajing dahong (Xinqiao), Baoan District, Shenzhen, Guangdong, China, 518000.
Establishment Registration Number: 3016652804
Contact Person: Qiyuan Ning Position: General Manager Tel: +86-755-27900876 Email: market(@fcy-medical.com
-
- Designated Submission Correspondent
Qiyuan Ning
- Designated Submission Correspondent
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO., LTD
Room. 1304, Technology Innovation Park, Shajing dahong (Xinqiao), Baoan District, Shenzhen, Guangdong, China, 518000.
Tel: +86-755-27900876 Email: market(@fcy-medical.com
-
- US Agent
SOUTH BAY INNOVATION LLC
2525 Vista Industria Compton, CA US 90221
Contact Person: Yueting Zhu Phone: 213 2216243 Email: Ctb-lab@Outlook.com
4
- న్. Identification of Proposed Devices
Common Name: Surgical Mask Trade Name: Surgical Face Mask (Ear loops and Tie-on) Models: Show in Table 1.
Table 1 Surgical Face Mask Model Numbers of proposed devices
| Mask Style | Ear Loops | Tie-on |
|---|---|---|
| Level 2 | FCY-L2-E | FCY-L2-T |
| Level 3 | FCY-L3-E | FCY-L3-T |
Regulatory Information
Classification Name: Mask, Surgical Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital
Indication for use:
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 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.
Level 2 Face Mask Models: FCY-L2-E, FCY-L2-T Level 3 Face Mask Models: FCY-L3-E, FCY-L3-T
Device Description:
The Proposed device has one size 17.5 cm x 9.5 cm and two wear types of Ear Loops and Tie-On. They are available in blue and white colors and three barrier levels (Level 3) according to ASTM F2100:2019, The details show in below table:
| Specification | 17.5cm × 9.5cm | ||
|---|---|---|---|
| Models | Ear loops | Tie-on | |
| ASTM F2100 Level | Level 2 | Blue | Blue |
| White | White | ||
| Level 3 | Blue | Blue | |
| White | White |
The proposed Level 2 and Level 3 masks are the same product which can pass ASTM F2100-19 Level 2 / 11
5
2 & 3 at the same time; they are classified into level 3 just because of the marketing strategies. All the materials of proposed tie-on masks are included in ear loops masks. The outer layer, inner layer, middle melt-blown layer and PET coated iron wire nose clip of tie-on masks are exactly the same with ear-loop masks, the tie tapes of tie-on masks are same as the outer layer of white mask body but 3 layers folded and physically ultrasonic welding together.
The proposed mask can form a physical barrier by being worn on the mouth and nose of medical staff to protect both the patient and healthcare personnel from the spread of microorganisms, blood and body fluids, and particulate materials.
The proposed subject device, surgical face mask, operates by acting as a physical barrier. The barrier protects the medical staff, patient, and healthcare personnel from the spread of microorganisms, blood and body fluids, and particulate materials. The barrier goes over the mouth and nose of the user.
- Identification of Predicate Devices 6.
510(k) Number: K160269 Product Name: Surgical Face Masks (Ear loops and Tie-on) Models: Show in Table 2
| Mask Style | Ear loops | Tie-On |
|---|---|---|
| Level 1 | EL 10000 | TO 10000 |
| Level 1 with Visor | EL 10010 | TO 10010 |
| Level 2 | EL 20000 | TO 20000 |
| Level 2 with Visor | EL 20010 | TO 20010 |
| Level 3 | EL 30000 | TO 30000 |
| Level 3 with Visor | EL 30010 | TO 30010 |
Table 2 Surgical Face Mask Model Numbers of predicate devices
-
- Non-Clinical Test Conclusion
The test results demonstrated that the proposed devices are in compliance with the following standards:
- Non-Clinical Test Conclusion
-
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) [FR Recognition #6-406]
-
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
-
A ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus [FR
3 / 11
6
Recognition #6-427]
-
16 CFR 1610 Standard for the Flammability of Clothing Textiles Corrections
- A ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks [FR Recognition #6-425]
-
EN 14683:2019+AC: 2019 Annex C Medical face masks. Requirements and test methods
- A ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity [FR Recognition #2-245]
-
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization.[FR Recognition #2-174]
- Clinical Test Conclusion 8.
No clinical study is included in this submission.
7
9. Summary of Technological Characteristics
| ITEM | Proposed Device K210225 | Predicate Device K160269 | Remark | ||||
|---|---|---|---|---|---|---|---|
| Surgical Face Mask | Surgical Face Masks | ||||||
| (Ear loops and Tie-on) | (Ear loops and Tie-on) | ||||||
| Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |||
| Product Code | FXX | FXX | Same | ||||
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | ||||
| Class | II | II | Same | ||||
| Indication for Use | 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 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. | |||||||
| Level 2 Face Mask Models: # FCY-L2-E, FCY-L2-T | |||||||
| Level 3 Face Mask Models: # FCY-L3-E, FCY-L3-T | 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 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. | |||||||
| Level 1 Face Mask Models: # EL 10000, EL 10010, | |||||||
| TO 10000, TO 10010 | |||||||
| Level 2 Face Mask Models: # EL 20000, EL 20010, | |||||||
| TO 20000, TO 20010 | |||||||
| Level 3 Face Mask Models: # EL 30000, EL 30010, | |||||||
| TO 30000, TO 30010 | Same | ||||||
| Mask style | Flat pleated | Flat pleated | Same | ||||
| Design feature | Ear loops/ Tie-on | Ear loops/ Tie-on | Same | ||||
| Dimension (mm) | Ear loops: Body: 175 mm×95 mm, nose clip: 105mm, | ||||||
| Earl oops: 200mm | 175 mm×90 mm | ||||||
| 180 mm×90 mm | Different | ||||||
| Different size | |||||||
| Analysis 1 | |||||||
| Tie-on: Body: 175 mm×95 mm, nose clip: 105mm, Mask tie: 875mm | |||||||
| Level | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Same | |
| Fluid resistance | Pass at 120mmHg | Pass at 160mmHg | Pass at 80mmHg | Pass at 120mmHg | Pass at 160mmHg | Same | |
| Particulate | |||||||
| efficiency level | Pass at 99.5% | Pass at 99.5% | Pass at 99.6% | Pass at 99.6% | Pass at 99.7% | Similar, | |
| Same test and pass, | |||||||
| different data, | |||||||
| Analysis 2 | |||||||
| Bacterial filtration | |||||||
| level | Pass at 99.9% | Pass at 99.9% | Pass at >98% | Pass at >98% | Pass at >99% | Similar, | |
| Same test and pass, | |||||||
| different data, | |||||||
| Analysis 3 | |||||||
| Differential | |||||||
| pressure | Pass at 3.6mmH2O/cm² | Pass at 3.6mmH2O/cm² | Passed at 2.0 mmH2O/cm² | Passed at 1.6 mmH2O/cm² | Passed at 2.5 mmH2O/cm² | Different, | |
| Both reports pass, | |||||||
| Using different | |||||||
| Recognized Consensus | |||||||
| Standards. Analysis 4 | |||||||
| Flammability | Class 1 | Class 1 | Same | ||||
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | ||||
| Materials | |||||||
| Outer layer | |||||||
| Material | 25g/m² non-woven fabric (Polypropylene) | Polypropylene | Similar, | ||||
| No weight/unit data | |||||||
| available for predicated | |||||||
| device |
Table 3 Comparison of Surgical Face Mask
8
9
| Analysis 5 | |||
|---|---|---|---|
| Inner layer | |||
| Material | 25g/m² non-woven fabric (Polypropylene) | Polypropylene | Similar, |
| No weight/unit data | |||
| available for predicated | |||
| device | |||
| Analysis 6 | |||
| Middle layer | |||
| Material | 25g/m² melt blown (Polypropylene) | 1. Polypropylene spunbond |
- Polypropylene meltblown | Different,
1 middle layer of proposed
device while 2 middle
layers of predicated
device, Analysis 7 |
| Nose Clip | PET (Polyethylene terephthalate) coated Iron wire | Polyethylene coated steel wire | Different,
Iron wire of proposed
device while steel wire of
predicated device
Analysis 8 |
| Ear Loops | Polyurethane, Poly[imino(1-oxo-1,6-hexanediyl)] | Polyester, Polyurethane, Side tapes: Polyester
spunbond (ear loops mask only) | Different,
Different fiber composition
Analysis 9 |
| Tie Tapes | Non-woven fabric (Polypropylene) | Polypropylene spunbond or Polyester spunbond | Different,
1 kind of composition for
proposed device while 2
kinds of composition for
choosing for predicated
device
Analysis 10 |
| Colors | blue and white | blue and white | Same |
10
| Biocompatibility | |||
|---|---|---|---|
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Sensitization | No Sensitization | No Sensitization | Same |
| Irritation | No Irritation | No Irritation | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
Analysis 1 - Dimension (mm)
The dimension of the proposed devices is different from predicate devices.
Dimensions of proposed device (Far loops: Body: 105mm, nose clip: 105mm, Tie-on: Body: 175 mm >95 mm, nose clip: 105mm, - Mask tie: 875mm), while predicated device (175 mm×90 mm). The size of proposed device can cover an adult's mouth and nose, the performance testing pass level 2, 3. It can fulfill its finction and intended use to protect the wearer. The materials used are biocomatible which are supported by biocompatibility testing, we also instructions on the labeling and user manual. Therefore, the dimensional difference does not affect the safety and effectiveness between the proposed devices and predicate devices.
Analysis 2 - Particulate efficiency level
The test result of particulate filtration efficiency for the proposed devices. However, the test result of the proposed devices can meet the requirements of level 3 according to ASTM F2299F2299M-17. Therefore, this difference does not affect the safety and effectiveness of proposed devices.
Analysis 3 - Bacterial filtration level
The test result of bacteria filtration efficiency for the proposed devices. However, the test result for the proposed devices can meet the requirements of level 3 according to ASTM F2100-19 and ASTM F2101-19. Therefore, the stiffect the safety and effectiveness of proposed device.
Analysis 4 - Differential pressure
The test result and reference standard of differential proposed devices are different from predicate devices. The test method of
11
differential presure for proposed devices is EN14683:2019+AC: 2019 Amex C, while for predicate devices is ML-M36945C. This difference is due to the fact that the standard EN14683:2019 is approved by FDA instead of mil-M3694SC. Meanwhile, the test result of proposed devices can meet the requirements of level 2/ level 3 according to ASTM F2100-19 and EN14683:2019 Amex C. Therefore, this difference does not affect the safety and effectiveness of proposed devices.
Analysis 5 - Outer Material
The Outer Material of proposed devices is 25g/m² non-woven fabric (Polypropylene) and the predicate devices is Polypropylene. Both the two materials refer to the non-woven fabric which is made of polypropylene. The performance test and biocompatibility test were performed, under the conditions of the study, the device was found to be non-sensitizing and non-irritating, so that the material differences will not affect the issue of safety and effectiveness of proposed devices.
Analvsis 6 - Inner Material
The Inner Material of proposed devices is 25g/m² non-woven fabric (Polypropylene) and the two materials refer to the non-woven fabric which is made of polypropylene. The performance test and biocompatibility test were performed, under the conditions of the study, the device was found to be non-sensitizing and non-irritating, so that the material differences will not affect the issue of safety and effectiveness of proposed devices.
Analysis 7 - Middle layer material
The middle layer material of proposed device is 25g/m² met blown (Polypropylene), while the predicate spurbond and Polypropylene met-blown. Both the two melt blown fabric which is made of polypropylene. The performance test and biocompatibility test were performed, under the study, the device was found to be non-cytotoxic, non-senstizing and non-irritating, so that the material differences will not affect the issue of safety and effectiveness of proposed devices.
Analysis 8 - Nose Clip
The materials of Nose Clip for proposed devices. The materials of Nose Clip for proposed devices are PET (Polyethylene terephthalate) coated Iron wire while the predicate devices are wire. The performance test and biocompatibility test were performed, under the conditions of the device was found to be non-cytotoxic, non-senstizing and non-irritating, so that the material
12
differences will not affect the issue of safety and effectiveness of proposed devices.
Analysis 9 - Ear Loops
The materials of Ear Loops for proposed devices are partly different from predicate devices. The materials of Ear Loops for proposed devices are Polyurethane and Polylimino(1-oxo-1,6-hexanedyl)) while the predicate devices is Polyester and Polyurethane. The performance test and biocompatibility test were performed, under the study, the device was found to be non-cytotoxic, non-sensitizing and non-inftating, so that the material differences will not affect the issue of safety and effectiveness of proposed devices.
Analysis 10 - Tie Tapes
The material of Tie Tapes for proposed devices is partly different from predicate devices. The material of Tie Tapes is non-woven fabric (Polypropylene) while the predicate devices are Polyester spunbond. The performance test and biocompatibility test were performed, under the conditions of the device was found to be non-cytotoxic, non-sensitizing and non-irritating, so that the material differences will not affect the issue of safety and effectiveness of proposed devices.
13
10. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210225, the Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160269.