(120 days)
Not Found
No
The device description and performance testing focus on the physical properties and filtration capabilities of a disposable face mask, with no mention of AI or ML.
No.
The device is a face mask intended for infection control by creating a barrier, not to treat a disease or condition.
No
The device is a DISPOSABLE FACE MASK, intended for protection against transfer of microorganisms and particulate material, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, multi-layered face mask with ear loops and a nose clip, made of non-woven materials and wire. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting 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 test performed in vitro (outside the body).
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose clip). There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask, such as filtration efficiency, differential pressure, resistance to fluid penetration, and flame spread. These are relevant to its function as a barrier, not as a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This face mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The DISPOSABLE FACE MASK is 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.
Product codes
FXX
Device Description
The DISPOSABLE FACE MASK is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven the model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The nose clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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)
Performance Testing summary:
- Bacterial filtration efficiency: ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus according to ASTM F2100:2019. Results: 99.84% / Pass (Model: TX-005), 99.83% / Pass (Model: TX-006).
- Differential pressure (Delta-P): EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019. Results: 4.9 mm H2O/cm² / Pass (Model: TX-005), 5.0 mm H2O/cm² / Pass (Model: TX-006).
- Sub-micron particulate filtration efficiency at 0.1 µm of Polystyrene Latex Spheres: ASTM F2299-03 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres according to ASTM F2100:2019. Results: 98.60% / Pass (Model: TX-005), 98.57% / Pass (Model: TX-006).
- Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result: 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) according to ASTM F2100:2019. Results: Fluid Resistant claimed at 120 mm Hg / Pass (Model: TX-005), Fluid Resistant claimed at 160 mm Hg / Pass (Model: TX-006).
- Flame spread: 16 CFR Part 1610 Standard for the Flammability of Clothing according to ASTM F2100:2019. Results: Class 1 / Pass (Model: TX-005), Class 1 / Pass (Model: TX-006).
Biocompatibility Testing Summary:
According to ISO 10993-1: 2018, the nature of body contact for the subject device is the Surface Device category, Skin Contact, and duration of the contact is A-Limited (
§ 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 contains the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 24, 2022
Jiujiang Taixin Technology Co., Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510700 China
Re: K220191
Trade/Device Name: DISPOSABLE FACE MASK (Model: TX-005, TX-006) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 19, 2022 Received: April 25, 2022
Dear Cassie Lee:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for 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
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Indications for Use
510(k) Number (if known) K220191
Device Name DISPOSABLE FACE MASK (Model: TX-005, TX-006)
Indications for Use (Describe)
The DISPOSABLE FACE MASK is 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.
Type of Use (Select one or both, as applicable)
| Residential Use (Act 250/Section 248 Review) | Commercial or Industrial Use (Act 250/Section 248 Review) |
|---|---|
| ------------------------------------------------------------ | ------------------------------------------------------------------------- |
__ 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 of K220191
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Subject Device: DISPOSABLE FACE MASK (Model: TX-005, TX-006)
510(k) Number: K220191
- Date of the summary prepared: April 19, 2022
2. Submitter's Information
510(k) Owner's Name: Jiujiang Taixin Technology Co., Ltd. Establishment Registration Number: 3017207447 Address: Zone A, Ruichang Science and Technology Park, Ruichang City, Jiujiang City, Jiangxi Province, China Contact Person: Xiaojie Li Email: 43590288@qq.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446
3. Subject Device Information
Email: regulatory@share-info.com
Type of 510(k): Traditional Classification Name: Surgical Face Mask Trade Name: DISPOSABLE FACE MASK Model Name: TX-005, TX-006
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Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: II
4. Primary Predicate Device Information
Sponsor: Foshan Xinbao Technology Co., Ltd. Trade Name: Surgical Mask Common name: Surgical apparel Classification Name: Mask, Surgical 510(K) Number: K202424 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II
5. Indications for Use
The DISPOSABLE FACE MASK is 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.
6. Device Description
The DISPOSABLE FACE MASK is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven the model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural
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rubber latex.
The nose clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
7. Summary of Technological Characteristics
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | Jiujiang Taixin Technology Co., | ||
| Ltd. | Zhejiang The Purples Protective | ||
| Products Co.,Ltd | -- | ||
| 510 (k) | K220191 | K202424 | -- |
| Trade Name | DISPOSABLE FACE MASK | Surgical Mask | -- |
| Classification | Class II Device, FXX (21 | ||
| CFR 878.4040) | Class II Device, FXX (21 | ||
| CFR 878.4040) | Same | ||
| Intended use | The DISPOSABLE FACE MASK is | ||
| 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 Surgical Masks are intended | ||
| to be worn to protect both the | |||
| patient and healthcare personnel | |||
| from transfer of microorganisms, | |||
| body fluids, and particulate | |||
| material. These masks are | |||
| intended for use in infection | |||
| control practices to reduce | |||
| potential exposure to blood and | |||
| body fluids. | |||
| This is a single use, disposable | |||
| device, provided nonsterile. | Same | ||
| Outer facing | |||
| layer | Spunbonded non-woven | Spun-bond polypropylene | Similar |
| Note 1 | |||
| Middle layer | Melt-Blown non-woven | Melt blown polypropylene | Similar |
| Note 1 | |||
| Inner facing | |||
| layer | Melt-Blown non-woven | Spun-bond polypropylene | Similar |
| Note 1 | |||
| Nose clip | PE coated Tin-plate wire | Galvanized iron wire | Similar |
| Note 1 | |||
| Ear loops | Spandex | Nylon and Spandex | Similar |
| Note 1 | |||
| Color | white + blue | Blue | Similar |
| Note 1 | |||
| Specification | |||
| and | |||
| Dimension | 175mm×95mm | Width: 17.5cm±1cm | |
| Length: 9.5cm±1cm | Same | ||
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100 | |||
| Level | Level 3 | ||
| (Model: TX-006) | Level 2 | ||
| (Model: | |||
| TX-005) | Same | ||
| Fluid | |||
| Resistance | |||
| Performance | Pass at 160 mmHg | ||
| (Model: TX-006) | Pass at 120 mmHg | ||
| (Model: | |||
| TX-005) | Same | ||
| Particulate | |||
| Filtration | |||
| Efficiency | 98.57% | ||
| (Model: TX-006) | 98.6% | ||
| (Model: | |||
| TX-005) | Similar | ||
| Note 2 | |||
| Bacterial | |||
| Filtration | 99.83% | ||
| (Model: TX-006) | 99.84% | ||
| (Model: | |||
| TX-005) | Similar | ||
| Note 2 |
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| Efficiency | TX-005) | ||||
|---|---|---|---|---|---|
| Differential | |||||
| Pressure | 5.0mm | ||||
| H2 O/cm² | |||||
| (Model: TX-006) | 4.9mm | ||||
| H2 O/cm² | |||||
| (Model: | |||||
| TX-005) | Pass at |