(204 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier performance of a surgical mask, with no mention of AI or ML.
No
A therapeutic device is one that treats or alleviates a disease or condition. This surgical mask is intended to protect against the transfer of microorganisms and particulate materials, which is a preventive rather than therapeutic function.
No
The device is a surgical mask intended to prevent the transfer of microorganisms and bodily fluids, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (non-woven fabric, melt blown fabric, elastic ear loops, nose piece) and performance testing related to material properties and physical barriers, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Function: The description clearly states the device is a "DISPOSABLE SURGICAL MASK" intended to be worn on the face to protect against the transfer of microorganisms, body fluids, and particulate materials. It acts as a physical barrier.
- Lack of Specimen Analysis: There is no mention of the mask being used to analyze any biological specimens or provide diagnostic information about a patient's health based on such analysis.
- Performance Metrics: The performance metrics listed (BFE, PFE, Differential Pressure, Synthetic Blood Penetration Resistance, Flammability) are related to the physical barrier properties and safety of the mask, not to the accuracy or reliability of a diagnostic test.
The device described is a medical device, specifically a surgical mask, used for infection control and protection. It does not fit the definition or function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DISPOSABLE SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single- use and provided non-sterile.
Product codes
FXX
Device Description
The "DISPOSABLE SURGICAL MASK" is single use, blue color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The "DISPOSABLE SURGICAL MASK" is manufactured with three layers. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of iron strip and polypropylene. The"DISPOSABLE SURGICAL MASK" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Adults
Intended User / Care Setting
healthcare personnel / 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 data performance tests include:
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
- Bacterial Filtration Efficiency-Determine the bacterial filtration efficiency as directed in Test method F2101.
- Differential Pressure -Determine breathing resistance or differential pressure as directed in EN 14683:2019,Annex C.
- Sub-Micron Particulate Filtration-Determine particulate filtration efficiency as directed in Test Method F2299.
- Resistance to Penetration by Synthetic Blood-Determine synthetic blood penetration resistance as specified in Test Method F1862.
- Flammability-Determine flammability as specified in 16 CFR Part 1610.
Biocompatibility tests include:
- 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.
Key results: All tests were accepted and met Level 1 criteria, finding the device to be non-cytotoxic, non-sensitizing, and non-irritating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
BFE: Average 99.9%
PFE: Average 99.8%
Differential Pressure: Average 2.7
Synthetic Blood Penetration Resistance: 80
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.
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Image /page/0/Picture/0 description: The image shows 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 12, 2021
Jiaxing Amazing Travel-Ware CO., LTD Jiang Tao Head of Firm No.2196 Honggao Road, Xiuzhou Industrial Park Jiaxing, Zhejiang 314015 China
Re: K210845
Trade/Device Name: Disposable Surgical Mask (Model: YYKZ-01) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 6, 2021 Received: September 13, 2021
Dear Jiang Tao:
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); 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 Clarence W. Murray III, Ph.D. 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) K210845
Device Name DISPOSABLE SURGICAL MASK(Model: YYKZ-01)
Indications for Use (Describe)
The DISPOSABLE SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single- use and provided non-sterile.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: Sep. 23, 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | JIAXING AMAZING TRAVEL-WARE CO.,LTD |
|---|---|
| Address: | No.2196 Honggao Road, Xiuzhou Industrial Park |
| Jiaxing, Zhejiang, China 314015 | |
| Contact person: | Jiang Tao |
| Title: | Head of Firm |
| E-mail: | 175556919@qq.com |
| Tel: | +86-13957376195 |
2. Device Identification
| 510(k) Number: | K210845 |
|---|---|
| Trade/Device Name: | DISPOSABLE SURGICAL MASK |
| Models: | YYKZ-01 |
| Common name: | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FXX |
3. Predicate Device
| 510(K) number: | K202061 |
|---|---|
| Device Name: | Medical Face mask |
| Manufacturer: | Jiangsu Province Jianerkang Medical Dressing Co., Ltd |
| Common name | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FXX |
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Image /page/4/Picture/1 description: The image shows the word "JEGUN" in a stylized, sans-serif font. The letters are white against a light blue background. The "G" in "JEGUN" is particularly distinctive, with a unique, geometric design that sets it apart from the other letters.
4. Device Description
The "DISPOSABLE SURGICAL MASK" is single use, blue color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The "DISPOSABLE SURGICAL MASK" is manufactured with three layers. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of iron strip and polypropylene. The"DISPOSABLE SURGICAL MASK" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
5. Indication for use
The DISPOSABLE SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.
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Image /page/5/Picture/0 description: The image is a logo for JEGUN. The logo is white text on a blue background. The text is stylized and appears to be a custom font.
6. Comparison to Predicate Device
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table
| SE
Comparisons | Proposed Device
K210845 | Predicate Device
K202061 | Similarities/
Differences |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Name | DISPOSABLE SURGICAL
MASK | Single-use Surgical Mask | / |
| Model | YYKZ-01 | FE2311 | / |
| Classification | Class II | Class II | Same |
| Intended use/
Indications for
Use | The DISPOSABLE
SURGICAL MASK is
intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids, and particulate
materials in infection control
practices to reduce the
potential exposure to blood
and body fluids. It is for
single-use and provided
non-sterile. | The medical face mask is
intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids, and particulate
materials in infection control
practices to reduce the
potential exposure to blood
and body fluids. It is for
single-use and provided
non-sterile. | Same |
| ASTM F2100
Level | Level 1 | Level 1 | Same |
| Mask Styles | Flat Pleated | Flat Pleated | Same |
| Design features | Ear loop | Ear loop | Same |
| Layers | 3 | 3 | Same |
| Color | Blue | Blue | Same |
| Target
population | Adults | Adults | Same |
| Dimension
(length) | $175 \pm 5$ mm | 175 mm | Same |
| Dimension
(width) | $95 \pm 5$ mm | 95 mm | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Use | Single use, disposable | Single use, disposable | Same |
| Anatomical site | Nose and mouth | Nose and mouth | Same |
| Technology | Self-suction filter mask | Self-suction filter mask | Same |
| Environment of
use | OTC | OTC | Same |
| | | | |
| Material of
Outer layer | Non-woven fabric
(Polypropylene) | polypropylene | Same |
| Material of
middle layer | Melt blown fabric
(Polypropylene) | Melt blown polypropylene | Same |
| Material of
inner layer | Non-woven fabric
(Polypropylene) | polypropylene | Same |
| Material of
ear loops | Spandex and nylon | Spandex and nylon | Same |
| Material of
Nose piece | Iron strip and Polypropylene | Polypropylene coated steel
wire | Note 1 |
| Performance testing Data comparison | | | |
| BFE | Average 99.9% | Average 99.8% | Meet level 1 |
| PFE | Average 99.8% | Average 96.09% | Meet level 1 |
| Differential
Pressure | Average 2.7 | Average 3.9 | Meet level 1 |
| Synthetic Blood
Penetration
Resistance | 80 | 80 | Meet level 1 |
| Flammability | Class 1 | Class 1 | Meet level 1 |
| Biocompatibility comparison | | | |
| In Vitro
Cytotoxicity | Under the conditions of the
test, the test article was
found to be non- cytotoxic | Under the conditions of the
test, the test article was
found to be non- cytotoxic | Same |
| Skin
Sensitization | Under the conditions of the
test, the test article was
found to be non- sensitizing | Under the conditions of the
test, the test article was
found to be non- sensitizing | Same |
| Skin Irritation
test | Under the conditions of the
test, the test article was
found to be non- irritating | Under the conditions of the
test, the test article was
found to be non- irritating | Same |
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Image /page/6/Picture/0 description: The image shows the word "JEGUN" in a stylized, sans-serif font. The letters are white and the background is a light blue color. The letters are connected to each other, and the overall design is modern and sleek. The logo is simple and easy to read.
Note 1: The nose piece material of the subject device is iron with polypropylene covering. The predicate device uses polypropylene coated steel wire. The nose piece does not directly contact the user's skin. Biocompatibility testing was conducted on the final device, and the tests showed there was no biocompatibility risk. Performance testing was conducted according to ASTM F2100-19, and the test results show that the proposed device meets the level 1 requirements.
Otherwise, all of the specifications and materials of the subject device, DISPOSABLE SURGICAL MASK (model: YYKZ-01), are the same as the predicate device K202061 with no identified new risks.
7. Performance Data Clinical test:
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Image /page/7/Picture/1 description: The image shows the word "JEGUN" in a stylized font. The letters are white and the background is light blue. The letters are connected to each other, and the overall design is modern and sleek.
Clinical testing is not required.
Non-clinical data
The proposed device DISPOSABLE SURGICAL MASK:
Performance:
-
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
-
Bacterial Filtration Efficiency-Determine the bacterial filtration efficiency as directed in Test method F2101.
-
- Differential Pressure -Determine breathing resistance or differential pressure as directed in
EN 14683:2019,Annex C.
- Sub-Micron Particulate Filtration-Determine particulate filtration efficiency as directed in Test 4.
Method F2299
-
- Resistance to Penetration by Synthetic Blood-Determine synthetic blood penetration resistance as specified in Test Method F1862.
-
- Flammability-Determine flammability as specified in 16 CFR Part 1610.
| standa
| rd | Test item | Test method | Criteria | Results |
|---|---|---|---|---|
| ASTM | ||||
| F2100 | ||||
| -19 | BFE | ASTM F2101-19 | ≥95% | Accepted |
| PFE | ASTM F2299-03(2017) | ≥95% | Accepted | |
| Differential | ||||
| Pressure | EN | |||
| 14683 :2019+AC (2019)(E), | ||||
| Annex C | 90% humidity for 24 | |||
| hours. After the culture, the | ||||
| morphology and cell lysis of | ||||
| the cells were observed | ||||
| under the microscope, and | ||||
| the cytotoxicity of the test | ||||
| samples was determined by | ||||
| MTT assay. | The 50% extract of the test | |||
| article should have at least | ||||
| the same or a higher viability | ||||
| than the 100% extract. | ||||
| Otherwise the test should be | ||||
| repeated. | ||||
| The lower the Viab. % value, | ||||
| the higher the cytotoxic | ||||
| potential of the test article is. | ||||
| If viability is reduced to |