(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration efficiency of a medical face mask, with no mention of AI or ML.
No.
The device description and intended use focus on protection from microorganisms and fluids, not on treating a disease or condition.
No
Explanation: The device, a medical face mask, is described as intended to protect against transfer of microorganisms and particulate materials. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (polypropylene layers, spandex/nylon ear loops, steel wire nose piece) and performance metrics related to filtration and physical properties, indicating it is a physical medical device, not software-only.
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 against the transfer of microorganisms, body fluids, and particulate materials. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on specimens.
- Device Description: The description details the physical construction of the mask and its materials. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on the physical properties of the mask related to filtration efficiency, breathability, flammability, and resistance to penetration. These are not metrics typically associated with the performance of an IVD, which would involve sensitivity, specificity, accuracy in detecting analytes, etc.
- Lack of IVD-related information: There is no mention of sample types, analytical methods, or any other information relevant to an in vitro diagnostic test.
In summary, the device is a medical face mask designed for physical protection, not for diagnosing conditions or analyzing biological samples.
N/A
Intended Use / Indications for Use
The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The medical face mask is designed and manufactured by Haian Medigauze Co., Ltd . It is non-sterile and for single use.
The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device, which is made from steel wire, allows the user to fitthe face mask around their nose.
The product is level 1 according to ASTM F2100-19. The main parameters of the product are listed as follows:
- I Bacterial filtration efficiency (BFE) ≥95%
- . Sub-micron particle filtration efficiency ≥95%
- Differential pressure:
§ 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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November 4, 2021
Haian Medigauze Co., Ltd Weihua Xu General Manager Jiaoxie Industry Park, Haian Nantong, Jiangsu 226633 China
Re: K212471
Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 30, 2021 Received: August 6, 2021
Dear Weihua Xu:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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) K212471
Device Name Medical face mask
Indications for Use (Describe)
The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and 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
In accordance with 21 CFR 807.92 the following summary of information is provided:
-
- SUBMITTER
Haian Medigauze Co., Ltd. Jiaoxie Industry Park 226633 Haian, Jiangsu, PEOPLE'S REPUBLIC OF CHINA. Phone: +86-13901478762 +86-513-88240958 Fax:
- SUBMITTER
| Primary Contact Person: | Weihua Xu |
|---|---|
| General Manager | |
| Haian Medigauze Co., Ltd. | |
| Tel: (+86) -13901478762 | |
| Fax: (+86) -513-88240958 |
Date prepared Nov 3, 2021
-
- DEVICE
| Device name: | Medical Face mask |
|---|---|
| Common name: | Mask, Surgical |
| Regulation number: | 21 CFR 878.4040 |
| Regulation Class: | II |
| Product Code: | FXX |
3. PREDICATE DEVICE
K160269, Surgical Face Masks (Ear loops and Tie-on).
This predicate has not been subject to a design-related recall.
4. DEVICE DESCRIPTION
The medical face mask is designed and manufactured by Haian Medigauze Co., Ltd . It is non-sterile and for single use.
The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device, which is made from steel wire, allows the user to fitthe face mask around their nose.
The product is level 1 according to ASTM F2100-19. The main parameters of the product are listed as follows:
- I Bacterial filtration efficiency (BFE) ≥95%
- . Sub-micron particle filtration efficiency ≥95%
- Differential pressure: