(149 days)
Not Found
No
The device description and performance studies focus on the physical filtration properties of a face mask, with no mention of AI or ML.
No.
The medical face mask is intended to protect against the transfer of microorganisms, body fluids, and particulate materials, rather than to treat or cure a disease or condition.
No
The device is a medical face mask, intended to protect from transfer of microorganisms, body fluids, and particulate materials, which is a protective function, not a diagnostic one.
No
The device description clearly outlines a physical medical face mask made of various materials (polypropylene, spandex, nylon, steel wire) and describes its mechanical filtering function. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, diagnose conditions, or monitor treatment.
- Device Function: The description clearly states the medical face mask is intended to be worn to protect against the transfer of microorganisms, body fluids, and particulate materials. It works by filtering air.
- No Specimen Analysis: The device does not analyze any biological specimens from a patient. Its function is purely a physical barrier and filter.
The information provided about the device's intended use, description, and performance testing all align with it being a personal protective equipment (PPE) device, specifically a medical face mask, not an IVD.
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 Jiangsu Province Jianerkang Medical Dressing 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 allows the user to fit the face mask around their nose, which is made from steel wire.
It is a self-inhalation filter mask, which works by filtering the air containing microorganisms, body fluids, and particulate matters through the filter material of the mask before being inhaled or exhaled.
The product is level 1 according to ASTM F2100-19. The main parameters of the product are listed as followed:
- Bacteral filtration efficiency (BFE) ≥95%
- Sub-micron particle filtration efficiency ≥95%
- Different 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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December 23, 2020
Jiangsu Province Jianerkang Medical Dressing Co., Ltd Hongfang Tang Quality System Director No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town, Jintan Changzhou, Jiangsu 213251 China
Re: K202061
Trade/Device Name: Medical Face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 4, 2020 Received: November 12, 2020
Dear Hongfang Tang:
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 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.
CAPT Elizabeth Claverie, M.S. 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) K202061
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
Jiangsu Province Jianerkang Medical Dressing Co., Ltd. Jianerkang Road, Zhixi Industry Concentration Area, ZhixiTown,213251 Jintan No.1 Changzhou City, PEOPLE'S REPUBLIC OF CHINA. Phone: +86-13585416869
Fax: +86-519-8244 4628
| Primary Contact | Hongfang Tang |
|---|---|
| Person: | Quality System Director |
| Jiangsu Province Jianerkang Medical Dressing Co., Ltd | |
| Tel: (+86)-519-8244 4628 | |
| Fax: (+86) -519-8244 4745 |
Date prepared December 22th, 2020
-
- DEVICE
| Device Name: | Medical Face mask |
|---|---|
| Common name: | Mask, Surgical |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | 2 |
| Product Code: | FXX |
PREDICATE DEVICE 3.
K160269, Surgical Face Masks (Ear loops and Tie-on) This predicate has not been subject to a design-related recall.
-
- DEVICE DESCRIPTION
The medical face mask is designed and manufactured by Jiangsu Province Jianerkang Medical Dressing Co., Ltd. It is non-sterile and for single use.
- DEVICE DESCRIPTION
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 allows the user to fitthe
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face mask around their nose, which is made from steel wire.
It is a self-inhalation filter mask, which works by filtering the air containing microorganisms, body fluids, and particulate matters through the filter material of the mask before being inhaled or exhaled.
The product is level 1 according to ASTM F2100-19. The main parameters of the product are listed as followed:
- י Bacterial filtration efficiency (BFE) ≥95%
- . Sub-micron particle filtration efficiency ≥95%
- . Different pressure: