(69 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML technologies.
No.
The device is intended for protection against microorganisms and bodily fluids, not for treating or curing a disease or medical condition.
No
The device is a face mask intended for protection and infection control, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, multi-layered mask made of nonwoven fabrics with ear loops or tie tapes and a nose piece. The performance studies focus on physical properties like filtration efficiency, fluid resistance, and flammability, which are characteristic of hardware medical devices. There is no mention of software components or functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect patients and healthcare personnel from the transfer of microorganisms, body fluids, and particulate materials by being worn over the mouth and nose. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of a face mask, including materials and design features for wearing. There are no components or mechanisms described that would be used to perform a diagnostic test on a sample from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, breathability, flammability, biocompatibility). These are relevant to a protective device, not a diagnostic one.
- Predicate Devices: The predicate devices listed are "Surgical Face Masks," which are also protective devices, not IVDs.
In summary, the device's purpose, design, and testing are all consistent with a protective medical device (specifically, a surgical face mask), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The product is intended to be worn to protect both the patients and healthcare personnel from transfer of microorganisms, body fluids and particulate materials. These masks are intended for adult 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/sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The proposed devices are three-layer, flat pleated masks. It has two design styles, i.e. earloop and tie-on. Each mask is composed of a mask body, a nose piece, two ear loops or four tie tapes.
The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric.
The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four tie tapes welded to the mask body. The elastic ear loops are knitted elastic loops (made of nylon and spandex), and the tie tapes are made of polypropylene nonwoven fabric.
The nose piece is enclosed between the layers of face mask to allow the user to fit the face mask around their nose, which is an iron wire with polypropylene covering.
The proposed devices can simultaneously meet the requirements for the performance class of level 2 and level 3 specified in ASTM F2100.
Both of the two design styles are available non-sterile. They are intended to be single use, disposable devices.
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
adult use
Intended User / Care Setting
patients and healthcare personnel
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 similar to the predicate device. The tests were conducted according to the following standards, and the results conducted on the representative models, the sterile earloop masks and non-sterile earloop masks with the largest size, demonstrated that the proposed device complies with the following standards:
- ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for in Vitro cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- 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 F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- EN 14683:2019+AC:2019 Medical Face Masks Requirements and Test Methods
- ASTM F2299/F2299M-03(R2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- 16 CFR 1610 Standard for the Flammability of Clothing Textiles
- ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 11737-2:2019 Sterilization of medical devices Microbiological methods Part 2 Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Device
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F1886M-2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
Performance Testing (sample size: 3 lots, 32 per lot for most tests):
- Fluid Resistance (ASTM F1862): Sterile earloop mask, 17595mm passed at 120 mmHg (96 of 96) and 160 mmHg (96 of 96). Non-sterile earloop mask, 17595mm passed at 120 mmHg (96 of 96) and 160 mmHg (94 of 96).
- Bacterial filtration efficiency (BFE) (ASTM F2101): Sterile earloop mask, 17595mm average 99.6% (range 99.4%~99.7%). Non-sterile earloop mask, 17595mm average >99.9% (>99.9%).
- Particulate filtration efficiency (PFE) (ASTM F2299): Sterile earloop mask, 17595mm average 98.38% (range 97.64%~99.11%). Non-sterile earloop mask, 17595mm average >99.99% (range 99.88%~>99.9977%).
- Differential pressure (Delta-P) (EN 14683): Sterile earloop mask, 17595mm average 2.7 mmH₂O/cm² (range 2.4~3.4). Non-sterile earloop mask, 17595mm average 5.5 mmH₂O/cm² (range 4.3~5.9).
- Flammability (16 CFR 1610): Both sterile and non-sterile earloop masks were Class 1.
Biocompatibility Testing:
- In vitro Cytotoxicity (ISO 10993-5): Pass (extract non-cytotoxic).
- Skin Irritation (ISO 10993-10): Pass (polar and non-polar extracts non-irritating).
- Skin Sensitization (ISO 10993-10): Pass (polar and non-polar extracts non-sensitizing).
Clinical testing was not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance: Pass at 120mmHg and 160mmHg
- Bacterial Filtration Efficiency (BFE): Average: 99.6% (Sterile), Average: >99.9% (Non-sterile)
- Particulate Filtration Efficiency (PFE): Average: 98.38% (Sterile), Average: >99.99% (Non-sterile)
- Differential Pressure (Delta P): Average: 2.7 mmH2O/cm² (Sterile), Average: 5.5 mmH2O/cm² (Non-sterile)
- Flammability: Class 1
- Biocompatibility: non-cytotoxic, non-sensitizing, and 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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 11, 2022
Luoyang Sunmed Devices Co., Ltd. % Ms. Grace Liu Consultant Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K222335
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 2, 2022 Received: August 3, 2022
Dear Ms. Liu:
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); 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 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.
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222335
Device Name Surgical Mask
Indications for Use (Describe)
The product is intended to be worn to protect both the patients and healthcare personnel from transfer of microorganisms, body fluids and particulate materials. These masks are intended for adult 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/sterile/sterile/sterile/sterile/sterile/sterile/sterile/sterile/ste
| 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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3
510(k) Summary - K222335
1. Contact Details
1.1 Applicant information
| Applicant Name | Luoyang Sunmed Devices Co., Ltd. |
|---|---|
| Address | No. 8 Huaxia Road, Hi-Tech Zone, Luoyang Area of China (Henan) |
| Pilot Free Trade Zone | |
| Contact person | Tian Qian |
| Phone No. | +86-18637911566 |
| qtian@suntech-power.com | |
| Date Prepared | 2022-08-02 |
1.2 Submission Correspondent
| Image: Company Logo | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan | |
| District, Shenzhen, Guangdong Province, China | |
| Image: Chinese Characters | |
| Phone No. | +86-755-86069197 |
| Contact person | Grace Liu; Field Fu; |
| Contact person's e-mail | grace@cefda.com; field@cefda.com |
| Website | http://www.cefda.com |
2. Device Information
| Trade name | Surgical Mask |
|---|---|
| Common name | Surgical Face Mask |
| Classification name | Mask, Surgical |
| Review Panel | General Hospital |
| Product code | FXX |
| Device Class | II |
| Regulation No. | 21 CFR 878.4040 |
3. Legally Marketed Predicate Device
Primary predicate device
| Trade Name | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) |
|---|---|
| 510(k) Number | K202843 |
| Product Code | FXX |
| Manufacturer | B.J.ZH.F.Panther Medical Equipment Co., Ltd. |
4
Additional predicate device
| Trade Name | Surgical Face Mask (Non-sterile) |
|---|---|
| 510(k) Number | K212398 |
| Product Code | FXX |
| Manufacturer | Hubei Kimsoul Industrial Co., Ltd |
4. Device Description
The proposed devices are three-layer, flat pleated masks. It has two design styles, i.e. earloop and tie-on. Each mask is composed of a mask body, a nose piece, two ear loops or four tie tapes.
The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric.
The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four tie tapes welded to the mask body. The elastic ear loops are knitted elastic loops (made of nylon and spandex), and the tie tapes are made of polypropylene nonwoven fabric.
The nose piece is enclosed between the layers of face mask to allow the user to fit the face mask around their nose, which is an iron wire with polypropylene covering.
The proposed devices can simultaneously meet the requirements for the performance class of level 2 and level 3 specified in ASTM F2100.
Both of the two design styles are available non-sterile. They are intended to be single use, disposable devices.
5. Intended Use/Indication for Use
The product is intended to be worn to protect both the patients and healthcare personnel from transfer of microorganisms, body fluids and particulate materials. These masks are intended for adult 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/sterile.
6. Technological Characteristics Comparison
| Comparison item | Proposed Device
(K222335) | First Predicate Device
(K202843) | Second Predicate Device
(K212398) | Comment | |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer | Luoyang Sunmed
Devices Co., Ltd. | B.J.ZH.F.Panther Medical
Equipment Co., Ltd. | HUBEI KIMSOUL
INDUSTRIAL CO., LTD | None | |
| Product name | Surgical Mask | Surgical Face Masks
(Sterile), Surgical Face
Masks (Non-sterile) | Surgical Face Mask
(Non-sterile) | None | |
| Product Code | FXX | FXX | FXX | Same | |
| Regulation Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same | |
| Classification | Class II | Class II | Class II | Same | |
| OTC use | Yes | Yes | Yes | Same | |
| Indications for Use | The product is intended to
be worn to protect both
the patients and
healthcare personnel
from transfer of
microorganisms, body
fluids and particulate
materials. These masks
are intended for adult 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/sterile. | The Surgical Face Mask 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. | The 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 adult 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. | Similar | |
| Mask style | Flat-pleated, 3 layers | Flat-pleated, 3 layers | Flat-pleated, 3 layers | Same | |
| Design feature | Ear loop/Tie-on | Ear loop/Tie-on | Ear-loop | Same | |
| Single use | Yes | Yes | Yes | Same | |
| Color | Blue | Blue | White | Same | |
| Specifications and
dimensions | 1. 145mm×95mm
Nose piece:
85mm×3.0mm
Ear loop: 155mm×3.5mm
Tie tape: N.A.
2. 175mm×95mm:
Nose piece:
100mm×3.0mm
Ear loop: 190mm×3.5mm
Tie tape: 890mm×8.5mm | 1. 14.5cm×9cm:
Nose clip:
85mm×2.9mm
Ear loop: 180mm×3mm
Ties: 910mm×10mm
2. 17.5cm×9.5cm:
Nose clip:
100mm×2.9mm
Ear loop: 180mm×3mm
Ties: 910mm×10mm | 1. 145mm × 95mm
Nose piece:
95mm×2.8mm
Ear loop: 160mm×3.5mm
Tie tape: N.A.
2. 175mm×95mm
Nose piece:
105mm×2.8mm
Ear loop: 165mm×3.5mm
Tie tape: N.A. | Similar | |
| Sterility | Non-sterile/Sterile | Non-sterile/Sterile | Non-Sterile | Same | |
| Sterilization
method | EO (SAL: 10-6) | EO (SAL: 10-6) | N.A. | Same | |
| ASTM F2100 Level | Level 2, Level 3 | Level 2 | Level 3 | Different | |
| Labeling | Complied with 21
CFR
part 801 | Complied with 21 CFR part
801 | Complied with 21 CFR
part 801 | Same | |
| Materials | | | | | |
| Outer layer | Polypropylene spunbond
nonwoven | Polypropylene spunbond
nonwoven | Polypropylene spunbond
nonwoven | Same | |
| Middle layer | Polypropylene meltblown
nonwoven | Polypropylene meltblown
nonwoven | Polypropylene meltblown
nonwoven | Same | |
| Inner layer | Polypropylene spunbond nonwoven | Polypropylene spunbond nonwoven | Polypropylene spunbond nonwoven | Same | |
| Nose piece | Iron wire with polypropylene covering | Medical polypropylene and Q235 | Polyethylene (PE) | Different | |
| Ear loop | Nylon and spandex | Nylon and spandex | Polyester and Polyurethane | Same | |
| Tie tape | Polypropylene spunbond nonwoven | Polypropylene spunbond nonwoven | N.A. | Same | |
| Performances | | | | | |
| / | Sterile | Non-sterile | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) | Surgical Face Mask (Non-sterile) | / |
| Fluid Resistance (ASTM F1862) | Pass at 120mmHg and 160mmHg | Pass at 120mmHg and 160mmHg | Pass at 120mmHg | Pass at 160 mmHg | |
| Particulate Filtration Efficiency (ASTM F2299) | Average: 98.38% | Average: >99.99% | Average: 98.98% | Average: 99.6% | |
| Bacterial Filtration Efficiency (ASTM F2101) | Average: 99.6% | Average: >99.9% | Average: 98.92% | Average: ≥99.9% | Different |
| Differential Pressure (Delta P) (EN 14683) | Average: 2.7 mmH2O/cm² | Average: 5.5 mH2O/cm² | Average: 4.4 mmH2O/cm² | Average: 3.7 mmH2O/cm² | |
| Flammability (16CFR 1610) | Class 1 | Class 1 | Class 1 | Class 1 | |
| Biocompatibility | ISO 10993-5 and ISO 10993-10; Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing, and non-irritating. | ISO 10993-5 and ISO 10993-10; Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing, and non-irritating. | ISO 10993-5 and ISO 10993-10; Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing, and non-irritating. | ISO 10993-5 and ISO 10993-10; Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing, and non-irritating | Same |
Table 1 Technological Characteristics Comparison Table
5
6
The proposed device has the similar indication for use as the two predicate devices as well as comparable technical and biocompatibility properties and characteristics, and the differences don't raise any additional questions for safety and effectiveness, therefore, the proposed device is substantially equivalent to the predicate device.
7. Summary of Non-clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as
7
similar to the predicate device. The tests were conducted according to the following standards, and the results conducted on the representative models, the sterile earloop masks and non-sterile earloop masks with the largest size, demonstrated that the proposed device complies with the following standards (see Table 2 and 3):
-
ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for in Vitro cytotoxicity
-
ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization
-
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
-
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 F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
-
EN 14683:2019+AC:2019 Medical Face Masks Requirements and Test Methods
-
ASTM F2299/F2299M-03(R2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
-
16 CFR 1610 Standard for the Flammability of Clothing Textiles
-
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
-
ISO 11737-2:2019 Sterilization of medical devices Microbiological methods Part 2 Tests of sterility performed in the definition, validation and maintenance of a sterilization process
-
ISO 10993-7:2008 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals
-
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Device
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
-
ASTM F1886M-2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
8
| Table 2 Summary of Performance Testing | ||||
|---|---|---|---|---|
| Purpose | Acceptance | |||
| Criteria | ||||
| per ASTM | ||||
| F2100-19 | ||||
| (AQL=4.0%) | Results | |||
| (Statistics of three lots, 32 per lot) | ||||
| Test | Sterile erarloop | |||
| mask, 175*95mm | Non-sterile erarloop | |||
| mask, 175*95mm | ||||
| Fluid | ||||
| Resistance | ||||
| (ASTM F1862) | Verify the fluid | |||
| resistance of the | ||||
| proposed device can | ||||
| meet the requirements | ||||
| for Level 2 and 3 | ||||
| specified in ASTM | ||||
| F2100-19. | Level 2: | |||
| Pass at 120 | ||||
| mmHg | 96 out of 96 pass at | |||
| 120 mmHg | 96 out of 96 pass at | |||
| 120 mmHg | ||||
| Level 3: | ||||
| Pass at 160 | ||||
| mmHg | 96 out of 96 pass at | |||
| 160 mmHg | 94 out of 96 pass at | |||
| 160 mmHg¹ | ||||
| Bacterial | ||||
| filtration | ||||
| efficiency (BFE) | ||||
| (ASTM F2101) | Verify the bacterial | |||
| filtration efficiency of | ||||
| the proposed device | ||||
| can meet the | ||||
| requirements for Level | ||||
| 2 and 3 specified in | ||||
| ASTM F2100-19. | Level 2: | |||
| ≥98% |
Level 3:
≥98% | 99.4%~99.7%
(Average: 99.6%) | >99.9%
(Average: >99.9%) |
| Particulate
filtration
efficiency (PFE)
(ASTM F2299) | Verify the particulate
filtration efficiency of
the proposed device
can meet the
requirements for Level
2 and 3 specified in
ASTM F2100-19. | Level 2:
≥98%
Level 3:
≥98% | 97.64%99.11% ²>99.9977%
(Average: 98.38%) | 99.88%
(Average: >99.99%) |
| Differential
pressure
(Delta-P)
(EN 14683) | Verify the differential
pressure of the
proposed device can
meet the requirements
for Level 2 and 3
specified in ASTM
F2100-19. | Level 2: