(91 days)
Not Found
No
The 510(k) summary describes a standard medical protective mask made of layered materials with ear straps and a nose piece. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on material properties and filtration efficiency, not algorithmic performance.
No
The device is described as a "Medical Protective Mask" intended for infection control by preventing the transfer of microorganisms, body fluids, and particulate material. It is a protective barrier, not designed to provide a therapeutic effect or treat a medical condition.
No
The device is a Medical Protective Mask used for protection against microorganisms and particulate material. It does not diagnose any condition or disease.
No
The device description clearly outlines the physical components of a medical mask, including materials like polypropylene, elastic ear straps, and a nose piece. The performance studies also focus on physical properties and filtration efficiency, 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 samples taken from the body.
- Device Description: The description details the physical construction and materials of the mask. 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 (filtration efficiency, pressure resistance, blood penetration, flame spread) and biocompatibility. These are relevant to a protective barrier device, not a diagnostic test.
- Key Metrics: The key metrics reported are related to the mask's filtration and barrier capabilities, not diagnostic accuracy metrics like sensitivity, specificity, PPV, or NPV in the context of identifying a disease or condition.
IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This medical mask does not perform any such function.
N/A
Intended Use / Indications for Use
Medical Protective Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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 mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively.
The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The mask is a single use, disposable device, provided non-sterile in white color.
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 and conformed to the related recognized standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical face masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
Non-Clinical Testing:
- Bacterial filtration efficiency (BFE) (%): Result 99.9% (Acceptance Criteria ≥98)
- Different pressure (mmH2O/cm²): Result 3.6-4.2 mmH2O/cm² (Acceptance Criteria
§ 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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October 14, 2021
Qinhuangdao Taizhi Medical Technology Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K212205
Trade/Device Name: Medical Protective Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 8, 2021 Received: July 15, 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.
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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 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) K212205
Device Name Medical Protective Masks
Indications for Use (Describe)
Medical Protective Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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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510(k) Summary - K212205
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
1.0 Submitter's information
Name: Qinhuanqdao Taizhi Medical Technology Co., Ltd. Address: No.5, Small and Medium Enterprises Incubator Base, East Circular Economy Park, Haigang District, Qinhuangdao City, Hebei Province, China Phone Number: +86-13383659307 Contact: Ms. Fan Xifan Date of Preparation: 08/07/2021
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: Medical Protective Masks Common name: Surgical face mask Classification name: Mask, Surgical Style(s): Expanded chamber, Longitudinal fold, ear strap, 4 layers
3.0 Classification
Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Surgical apparel Panel:
4.0 Predicate device information
Manufacturer: Shandong Shengquan New Material Co., Ltd. Device: Protective Face Mask for Medical Use 510(k) number: K201537
5.0 Indication for Use Statement
Medical Protective Masks is intended to be worn to protect both the patient and
4
healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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 mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively.
The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The mask is a single use, disposable device, provided non-sterile in white color.
7.0 Non-Clinical Test Conclusion
The proposed device was tested and conformed to the related recognized standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical face masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
| Items | Performance | Acceptance Criteria
(Level 2, ASTM
F2100-19) | Result |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------|----------------------------------------------------|--------|
| Bacterial filtration
efficiency (BFE) (%) | 99.9% | ≥98 | Pass |
| Different pressure
(mmH2O/cm²) | 3.6-4.2 mmH2O/cm² |