(339 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard medical face mask, with no mention of AI or ML.
No
The device is a medical face mask, primarily intended for infection control by preventing the transfer of microorganisms and body fluids. It is not designed to treat a disease or condition.
No
Explanation: This device is a medical face mask. Its intended use is to protect the patient and healthcare personnel from microorganisms, body fluids, and particulate material, functioning as a barrier rather than for diagnosing any condition.
No
The device description clearly outlines a physical, multi-layer face mask made of nonwoven and melt-blown fabrics with ear loops and a nose piece. The performance studies focus on physical properties like filtration efficiency, pressure resistance, and flame spread, which are characteristic of hardware devices, not software.
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 individuals from the transfer of microorganisms, body fluids, and particulate material by being worn over the mouth and nose. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose piece). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies and Key Metrics: The performance studies focus on the physical and filtration properties of the mask (BFE, differential pressure, PFE, synthetic blood penetration, flame spread). These are tests of the mask's ability to act as a barrier, not tests to diagnose a condition or analyze a biological sample.
- No Mention of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This face mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Disposable medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face 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(s), provided non sterile.
Product codes
FXX
Device Description
The disposable medical face mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold non-sterile and 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
Not Found
Intended User / Care Setting
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
The proposed device was tested with three nonconsecutive lots (each lot had 32 samples for a total of 96 samples tested) and conformed to the related recognized 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:
- Bacterial filtration efficiency (BFE) (%): Pass (≥98)
- Differential pressure (mmH2O/cm²): Pass (
§ 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). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 23, 2021
Ningbo Jingeao Electronics Inc. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K202745
Trade/Device Name: Disposable medical face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 26, 2021 Received: July 26, 2021
Dear Boyle 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.
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
1
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 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) K202745
Device Name Disposable medical face mask
Indications for Use (Describe)
The Disposable medical face mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face 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(s), 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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3
510(k) Summary
510k number: K202745 Date: Aug.16, 2021 This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's information
Name: Ningbo Jingeao Electronics Inc. Address: No.2 Jinyuan Road, Longshan Industrial zone, Cixi City, Zhejiang Province, 315311, China Phone Number: 86-18800333393 Fax number: 86-574-63973722 Contact: Ms. Yiyun Yu Date of Preparation: Sep.10, 2020
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Disposable medical face mask Common name: Disposable medical face mask Classification name: Mask, Surgical Model(s): Ear loop, 175×95mm
3.0 Classification
Production code: FXX Requlation number: 21CFR 878.4040 Classification: Class II Panel: Surgical apparel
4.0 Predicate device information
Manufacturer: Wuhan Dymex Healthcare Co., Ltd Device: Surgical Face Mask 510(k) number: K182515 5.0 Indication for Use Statement
4
The Disposable medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face 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(s), provided non sterile.
6.0 Device description
The disposable medical face mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
| Table 3 - General Comparison | |||
|---|---|---|---|
| Item | Proposed device | Predicated device | Comparison |
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Product name | Disposable medical face mask | Surgical Face Mask | - |
| 510(k) No. | K202745 | K182515 | - |
| Models | Ear loop, 175×95mm | Ear loop | - |
| Intended Use | The Disposable medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face 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(s), provided non-sterile. | The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. | * Gap 1 |
| OTC use | Yes | Yes | Same |
| Composite | Flat Pleated. 3 layers | Flat Pleated. 3 layers | Same |
7.0 Technological Characteristic Comparison Table
5
| Material | Internal layer | Spun-bond polypropylene | Spun-bond polypropylene | Similar |
|---|---|---|---|---|
| Middle layer | Melt blown polypropylene | Melt blown polypropylene | Similar | |
| External layer | Spun-bond polypropylene | Spun-bond polypropylene | Similar | |
| Material | Nose piece | Galvanized iron wire | Malleable polyethylene wire | * Gap 2 |
| Material | Ear loop | Polyester, spandex | spandex | * Gap 3 |
| Color | Blue | Yellow | * Gap 4 | |
| Dimension (Length) | 17.5cm±0.5cm | 17.5cm±0.2cm | * Gap 5 | |
| Dimension (Width) | 9.5cm±0.5cm | 9.5cm±0.2cm | * Gap 6 | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Single Use | Yes | Yes | Same | |
| Sterile | No | No | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same |
- Gap analysis:
Gap 1: the proposed has sharper intended use than the predicate device, because the indication of the proposed device is within the scope of predicate device.
Gap 2-4: the two devices have some difference in materials and product color, product materials safety is proved by its biocompatibility.
Gap 5-6: the two devices share same dimensions however the tolerance is different.
8.0 _Non-Clinical Test Conclusion
The proposed device was tested with three nonconsecutive lots (each lot had 32 samples for a total of 96 samples tested) and conformed to the related recognized 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.
| Items | Purpose | Acceptance Criteria
(Level 2, ASTM
F2100-19) | Result |
|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------|--------|
| Bacterial filtration
efficiency (BFE) (%) | The purpose of the test
was to evaluate Bacterial
filtration efficiency (BFE)
(%) | ≥98 | Pass |
| Differential pressure
(mmH2O/cm²) | The purpose of the test
was to evaluate
Differential pressure
(mmH2O/cm²) |