(294 days)
k0450
No
The device description and performance studies focus on material properties and physical barrier function, with no mention of AI or ML.
No
The device is a medical mask intended for protection and infection control, not for treating or curing a disease or condition.
No
Explanation: The device description and intended use clearly state that this is a "Disposable Medical mask intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material." It is a barrier device for infection control, not a device used to identify or diagnose a disease or condition.
No
The device is a physical medical mask made of materials like polypropylene, with ear loops and a nose clip. The description focuses on its physical construction and performance characteristics related to filtration and fluid resistance, not software functionality.
No, 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 on a sample from the human body.
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose clip). There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, fluid resistance, flammability, breathability, biocompatibility). These are not studies related to the accuracy or reliability of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
In summary, this device is a medical mask intended for infection control through physical barrier protection, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Disposable Medical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The Disposable Medical mask is 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.
Model: k0450, blue color, and Level 2 barrier level per ASTM F2100.
Product codes
FXX
Device Description
Disposable Medical Mask are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose clip. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
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
patient 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
Surgical face mask has been evaluated the safety and effectiveness by lab bench testing according to the following standards:
- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
- ASTM F1862 Standard test method for resistance of Surgical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity).
- ASTM F 2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
During use, the Non-Woven Face Mask will directly contact with user's skin, so we have it tested to demonstrate conformance to the following standards.
- ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 5, 2004.
Key Results:
- Fluid Resistance Performance (mmHg): 32 out of 32 pass at 120 mmHg (Pass Criteria: 29 Out of 32 pass at 120 mmHg)
- Particulate Filtration Efficiency Performance (%): 99.9% (Pass Criteria: >= 98%)
- Bacterial Filtration Efficiency Performance (%): 99.9% (Pass Criteria: >= 98%)
- Flammability class: Class 1 (Pass Criteria: Class 1)
- Differential Pressure (Delta-P) (mm H2O/cm2):
§ 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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September 13, 2021
Fujian Kang Chen Daily Necessities CO., LTD Shuyan Wang Administrative Director No.55 Houdun Road, houmao Industrial Zone, Fengze District Quanzhou, Fujian 362000 China
Re: K203455
Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 5, 2021 Received: August 9, 2021
Dear Shuyan Wang:
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 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 (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.
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
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Indications for Use
510(k) Number (if known) K203455
Device Name Disposable Medical mask
Indications for Use (Describe)
The Disposable Medical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The Disposable Medical mask is 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.
Model: k0450, blue color, and Level 2 barrier level per ASTM F2100.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510k Summary
Prepared Date:09/13/2021
510k Number: 203455
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter Information
Sponsor : FUJIAN KANG CHEN DAILY NECESSITIES CO.,LTD
Address: No.55 Houdun Road, houmao Industrial Zone, Fengze District, Quanzhou
City, Fujian Province, China.
Contact Person: Shuyan Wang (Administrative Director)
Phone: +86-595-28892058
Fax:+86- 595-28892058
E-mail: shuyan@consoncompanies.com
2. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Surgical mask |
| Trade Name: | Disposable Medical Mask |
| Model: | k0450 |
| Classification Name: | Surgical Apparel |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
3. Predicate Device Information
| Sponsor: | Qiqihar Hengxin Medical Supplies,Ltd. |
|---|---|
| Common Name: | Surgical Mask |
| Trade Name: | Single-Use Surgical Face Mask with Ear Loop |
4
| 510(k) number: | K201691 |
|---|---|
| Model: | L |
| Classification Name: | Surgical Apparel |
|---|---|
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
4. Indications for Use
The Disposable Medical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The Disposable Medical mask 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.
Model: k0450, blue color, and Level 2 barrier level as ASTM F2100.
5. Device Description
Disposable Medical Mask are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose clip. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
6. Test Summary
Surgical face mask has been evaluated the safety and effectiveness by lab bench testing according to the following standards:
5
- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
- . ASTM F1862 Standard test method for resistance of Surgical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity).
- . ASTM F 2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
During use, the Non-Woven Face Mask will directly contact with user's skin, so we have it tested to demonstrate conformance to the following standards.
- ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- . ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Summary of Comparison and Technological Characteristics 7.
| Elements of
| Comparison | Subject Device | Predicate Device | Results | |
|---|---|---|---|---|
| Product Name | Disposable Medical | |||
| Mask (Model: k0450) | Single-Use Surgical | |||
| Mask with Ear Loop | ||||
| (Model:L) | -- | |||
| 510(k) Number | K203455 | K201691 | ||
| General Comparison | ||||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Results | |
| Indication for Use | The Disposable | |||
| Medical mask is | ||||
| intended to be worn | ||||
| to protect both the | ||||
| patient and | ||||
| healthcare personnel | ||||
| from the transfer of | ||||
| microorganisms, | ||||
| body fluids and | ||||
| particulate material. | ||||
| The Disposable | ||||
| Medical mask is | ||||
| 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. | ||||
| Model: k0450, blue | ||||
| color, and Level 2 | ||||
| barrier level as ASTM | ||||
| F2100. | The Single-Use surgical | |||
| mask with Ear Loop is | ||||
| intended to be worn to | ||||
| protect both the patient | ||||
| and healthcare | ||||
| personnel from the | ||||
| transfer of | ||||
| microorganisms, body | ||||
| fluids and particulate | ||||
| material. The Single-Use | ||||
| Mask with Ear Loop | ||||
| intended for use in | ||||
| infection control | ||||
| practices to reduce the | ||||
| potential exposure to | ||||
| blood and body fluids. | ||||
| This is a single use, | ||||
| disposable device(s), | ||||
| provided non-sterile. | ||||
| Model:M and L, blue | ||||
| color, and Level 2 barrier | ||||
| level as ASTM F2100 | Same | |||
| Model | 3 layers, Ear Loops, | |||
| Flat-Pleated Style | 3 layers, Ear Loops, | |||
| Flat-Pleated Style | ||||
| Material | Outer | |||
| facing layer | Spun-bond | |||
| polypropylene | Spun-bond non-woven | |||
| fabric | Different | |||
| Note 1 | ||||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Results | |
| Middle | ||||
| layer | Melt blown | |||
| polypropylene filter | Melt blown non-woven | |||
| fabric | Different | |||
| Note 2 | ||||
| Inner | ||||
| facing layer | Spun-bond | |||
| polypropylene | Spun-bond non-woven | |||
| fabric | Different | |||
| Note 3 | ||||
| Nose clip | aluminum wire coated | |||
| by polyethylene. | Malleable aluminum | |||
| wire | Different | |||
| Note4 | ||||
| Ear loops | Spandex | Polyester | Different | |
| Note 5 | ||||
| Color | Blue | Blue | Same | |
| Dimension (Width) | 9.5cm ± 0.5cm | 9.0cm ± 1.0cm | Different | |
| Note 6 | ||||
| Dimension (Length) | 17.5cm ± 0.5cm | 18.0cm ± 1.0cm | ||
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use | Single Use | Same | |
| ASTM F2100 Level | Level2 | Level 2 | Same | |
| Fluid Resistance | ||||
| Performance (mmHg) | 32 out of 32 pass at 120 | |||
| mmHg | 31 Out of 32 pass at | |||
| 120 mmHg | Similar | |||
| Particulate Filtration | ||||
| Efficiency | ||||
| Performance (%) | 99.9% | ≥ 99% | Same | |
| Bacterial Filtration | ||||
| Efficiency | ||||
| Performance (%) | 99.9% | ≥ 99% | Same | |
| Flammability class | Class 1 | Class 1 | Same | |
| Differential Pressure | ||||
| (Delta-P) | ||||
| (mm H2O/cm2) |