(206 days)
Not Found
No
The device is a simple physical barrier (face mask) and the description focuses on material composition and physical performance characteristics, with no mention of AI/ML or data processing capabilities.
No.
The device is a medical face mask intended to protect against transfer of microorganisms and particulate material, primarily for infection control. It does not treat or cure a disease or medical condition, which is the function of a therapeutic device.
No
Explanation: The device is a medical face mask designed to protect against microorganisms, body fluids, and particulate matter. It filters air and serves as a barrier, rather than diagnosing a condition or disease.
No
The device description clearly outlines physical components like nonwovens, ear loops/tie tapes, and a nose piece, indicating it is a hardware 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 is to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction and materials of a face mask designed for filtration. It does not describe any components or processes related to analyzing biological samples or providing diagnostic information.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on the physical properties and filtration capabilities of the mask (e.g., filtration efficiency, pressure resistance, flammability, biocompatibility). These are relevant to a protective barrier device, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This face mask does not perform any such function.
N/A
Intended Use / Indications for Use
The Single-use Medical 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Single-use Medical Face Mask is designed and manufactured by Conod Medical Co., Limited. It is non-sterile and for single use.
The Single-use Medical Face Mask has two models, Earloop and Tie Coverall. It is made of three-layer nonwovens, ear loops (for Earloop model)/ tie tapes (for Tie Coverall model) and nose piece. Inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops/ tie tapes are held in place over the users' mouth and nose by two elastic ear loops/ tie tapes welded to the mask. The ear loops are made of polyester, and the tie tapes are made of spun-bond polypropylene. The nose piece in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable aluminum wire.
It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.
The product is level 2 according to ASTM F2100-19. The main parameters of the product are listed as followed:
- . Bacterial filtration efficiency (BFE) >= 98%
- . Sub-micron particle filtration efficiency >= 98%
- . Different pressure: = 98% (3 non-consecutive lots, 32 samples per lot) - Pass
- Differential Pressure: = 98% (3 non-consecutive lots, 32 samples per lot) - Pass
- Resistance to Penetration by synthetic blood: Pass at 120 mmHg (3 non-consecutive lots, 32 samples per lot) - Pass
Biocompatibility tests included:
- Cytotoxicity: Pass
- Sensitization: Pass
- Skin Irritation: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial filtration efficiency (BFE) >= 98%
- Sub-micron particle filtration efficiency >= 98%
- 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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July 2, 2021
Conod Medical Co., Limited % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K203591
Trade/Device Name: Single-use Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 6, 2021 Received: May 12, 2021
Dear Olivia Meng:
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.
Clarence W. Murray, III, PhD 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) K203591
Device Name Single-use Medical Face Mask
Indications for Use (Describe)
The Single-use Medical 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.
| 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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Image /page/3/Picture/0 description: The image shows the word "CONOD" in large, bold, blue letters. The letters are sans-serif and appear to be slightly italicized. The word is the main focus of the image and is positioned horizontally.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
1. SUBMITTER
Conod Medical Co., Limited No.11 Hongfeng Road, Baimao Industrial Park, Guli Town, Changshu City, Jiangsu Province, China Phone: +86-0512-52306320 Fax: +86-0512-52301831
| Primary Contact Person: | Olivia Meng |
|---|---|
| Regulatory Affairs Manager | |
| Guangzhou Osmunda Medical Device Technical Service Co., Ltd. | |
| Tel: (+86)-20-6231 6262 | |
| Fax: (+86)-20-8633 0253 | |
| Secondary Contact Person: | Ms. Carrie Wu |
| Compliance Director | |
| Conod Medical Co., Limited | |
| Phone: +86-0512-52306320 | |
| Fax: +86-0512-52301831 | |
| Date prepared | May 6th, 2021 |
- DEVICE
| Device Name: | Single-use Medical Face Mask |
|---|---|
| Common name: | Mask, Surgical |
| Model: | Earloop: ARR-DMM-175-50 |
| ARR-DMM-165-50 | |
| ARR-DMM-145-50 | |
| Tie Coverall: ARR-DTM-175-50 | |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | II |
| Product Code: | FXX |
- PREDICATE DEVICE
K202719, Disposable Medical Face MasksThis predicate has not been subject to a design-related recall.
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DEVICE DESCRIPTION 4.
The Single-use Medical Face Mask is designed and manufactured by Conod Medical Co., Limited. It is non-sterile and for single use.
The Single-use Medical Face Mask has two models, Earloop and Tie Coverall. It is made of three-layer nonwovens, ear loops (for Earloop model)/ tie tapes (for Tie Coverall model) and nose piece. Inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops/ tie tapes are held in place over the users' mouth and nose by two elastic ear loops/ tie tapes welded to the mask. The ear loops are made of polyester, and the tie tapes are made of spun-bond polypropylene. The nose piece in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable aluminum wire.
It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.
The product is level 2 according to ASTM F2100-19. The main parameters of the product are listed as followed:
- . Bacterial filtration efficiency (BFE) ≥ 98%
- . Sub-micron particle filtration efficiency ≥ 98%
- . Different pressure: