(60 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration efficiency of a medical mask, with no mention of AI or ML technologies.
No
The device is a protective mask designed to prevent the transfer of microorganisms and particulate matter, not to treat a disease or condition.
No
This device is a protective mask designed to prevent the transfer of microorganisms and fluids. It does not gather information about a patient's health status or condition, which is the primary function of a diagnostic device.
No
The device description clearly outlines physical components (spun-bond polypropylene, melt-blown polypropylene, non-woven polypropylene filters, elastic ear straps, PE with dual-Galvanized wire nose piece) and performance testing related to physical properties (filtration efficiency, pressure, resistance to penetration, flame spread, biocompatibility), indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Description and Intended Use: The provided information clearly describes a Medical Protective Mask. Its intended use is to be worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier device used on the body, not a device used to analyze samples from the body.
- Testing Performed: The performance studies listed (BFE, Different pressure, PFE, Resistance to penetration by synthetic blood, Flame spread, Biocompatibility) are all tests related to the physical properties and protective capabilities of a mask, not diagnostic tests on biological samples.
Therefore, based on the provided information, the Medical Protective Mask is a personal protective equipment (PPE) device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Medical Protective Masks is 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 (comma separated list FDA assigned to the subject device)
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 black 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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) (%) | 99.0%-99.8% | ≥98 | Pass |
| Different pressure (mmH2O/cm²) | 2.8-4.0 mmH2O/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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Image /page/0/Picture/0 description: The image contains 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 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.
February 7, 2023
Qinhuangdao Taizhi Medical Technology Co., Ltd. % Mr. Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608. No.738 Shangcheng Rd. Pudong Shanghai, Shanghai 200120 China
Re: K223686
Trade/Device Name: Medical Protective Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 9, 2022 Received: December 9, 2022
Dear Mr. 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.
Katherine D. Kavlock -S
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) K223686
Device Name Medical Protective Masks
Indications for Use (Describe)
Medical Protective Masks is intended to be worn to protect both the patient and healthcare persomel 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
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: Qinhuangdao Taizhi Medical Technology Co., Ltd. Address: 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: 18/11/2022
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 Panel: Surgical apparel
4.0 Primary Predicate device information
Manufacturer: Qinhuangdao Taizhi Medical Technology Co., Ltd. Device: Medical Protective Masks 510(k) number: K212205
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 black 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) (%) | 99.0%-99.8% | ≥98 | Pass |
| Different pressure
(mmH2O/cm²) | 2.8-4.0 mmH2O/cm² |