(22 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
The device description and intended use clearly state that the device is a Disposable Surgical Mask used for protection from microorganisms and fluids, intended for infection control practices, not for therapeutic purposes like treating or diagnosing a medical condition.
No
A diagnostic device is used to diagnose a condition. This device is a surgical mask, intended to protect from microorganisms and body fluids, not to diagnose a medical condition.
No
The device description clearly outlines a physical, multi-layered mask made of polypropylene with ear loops and a nose piece. It is a tangible hardware product, not software.
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 against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose piece). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, fluid resistance, breathability, flammability) and biocompatibility. These are relevant to a barrier device, not a diagnostic test.
- Key Metrics: The key metrics are related to the mask's ability to filter and resist fluids, which are physical performance characteristics. Diagnostic metrics like sensitivity, specificity, PPV, and NPV are not applicable.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
The Disposable Surgical Mask, FILTECH M201 is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. The disposable surgical mask 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
FILTECH M201 Disposable Surgical Mask is a single use, that-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with latex materials, but are made of spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of malleable polyethylene wire. The surgical mask will be provided in blue of outside and white of inside. FILTECH M201 Disposable Surgical Mask is provided non-sterile and for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
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 subjected to non-clinical performance tests for Fluid Resistance (ASTM F1862), Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (Delta-P) (MIL-M-36954C), and Flammability class (16CFR 1610).
For Fluid Resistance, 32 out of 32 samples passed at 120mmHg, meeting the acceptance criterion of 29 out of 32 pass at 120mmHg.
For Particulate Filtration Efficiency, the proposed device achieved 98%, meeting the acceptance criterion of >= 98%.
For Bacterial Filtration Efficiency, the proposed device achieved 99.6%, meeting the acceptance criterion of >= 98%.
For Differential Pressure, the proposed device measured 5.5mmH2O/cm², meeting the acceptance criterion of
§ 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.
0
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September 18, 2020
Unisources Group LLC % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street. Ste. 403 Ludlum, Florida 33155
Re: K202463
Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 26, 2020 Received: August 27, 2020
Dear Rafael Aguila:
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.
1
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 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202463
Device Name
Disposable Surgical Mask
Indications for Use (Describe)
The Disposable Surgical Mask, FILTECH M201 is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. The disposable surgical mask 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) | |||
|---|---|---|---|
| ☐ Exporting Items with EAR99 Designations Only☒ Items That Incorporate USML-Controlled Items | ☐ Exporting Items with EAR99 Designations Only | ☒ Items That Incorporate USML-Controlled Items | |
| ☐ Exporting Items with EAR99 Designations Only | ☒ Items That Incorporate USML-Controlled Items |
| | 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 [As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K202463 |
|---|---|
| Date: | September 18th, 2020 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Applicant/US importer: | UNISOURCES GROUP LLC |
| 7460 NW 52 street, Miami, Florida, 33166, USA | |
| Manufacturer: | HANGZHOU FILTECH INTELLIGENT CO., LTD |
| Room 302, Building 9, No. 360 Tianmushan West Road, Yuhang Street | |
| Yuhang District, Hangzhou, Zhejiang, China 311121 | |
| Contact person: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description:
| Proprietary Name: | Disposable Surgical Mask |
|---|---|
| Model | FILTECH M201 |
| Common Name: | Surgical mask |
| Classification Name: | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Product Code: | FXX |
| Device Class: | II |
| Review Panel: | General Hospital |
3. Predicate device
Surgical Face Mask, K182515 WUHAN DYMEX HEALTHCARE CO., LTD This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
4. Device Description
FILTECH M201 Disposable Surgical Mask is a single use, that-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with latex materials, but are made of spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of malleable polyethylene wire. The surgical mask will be provided in blue of outside and white of inside. FILTECH M201 Disposable Surgical Mask is provided non-sterile and for single use.
4
5. Indication for use
The Disposable Surgical Mask, FILTECH M201 is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical Mask 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. Comparison of technological characteristics with the predicate device:
Table 1 General comparison
| Device | Proposed device | Predicate device | Result |
|---|---|---|---|
| 510(k) Holder | UNISOURCES GROUP LLC | WUHAN | |
| DYMEX | |||
| HEALTHCARE CO., LTD | -- | ||
| 510(k) Number | K202463 | K182515 | -- |
| Name | Disposable Surgical Mask | Surgical Face Mask | -- |
| Model | FILTECH M201 | / | -- |
| Classification | Class II Device, FXX (21 CFR 878.4040) | Class II Device, FXX (21 CFR 878.4040) | Same |
| Intended use | The Disposable Surgical Mask, FILTECH M201 is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical Mask 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. | The Surgical 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. | Same |
| Mask style | Flat Pleated | Flat Pleated | Same |
| Design | Ear loop | Ear loop | Same |
| Layers | Three | Three | Same |
| Color | Blue outside; white inside | Yellow | Similar |
| Note 1 | |||
| Target population | Adults | Adults | Same |
| Dimension (Length) | $175mm\pm5mm$ | $17.5cm\pm0.2cm$ | Similar |
| Dimension (Width) | $95mm\pm5mm$ | $9.5cm\pm0.2cm$ | Note 2 |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single use, disposable | Single use, disposable | Same |
| Anatomical site | Nose and mouth | Nose and mouth | Same |
| Technology | Self-suction filter mask | Self-suction filter mask | Same |
| Environment of use | OTC | OTC | Same |
| Outer facing layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Inner facing layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Ear loops | Spandex | Spandex | Same |
| Nose piece | Malleable polyethylene wire | Malleable polyethylene wire | Same |
| Colorants | Polypropylene (PP) master batch | Unknown | Similar |
| Note 1 | |||
| ASTM F2100 Level | Level 2 | Level 2 | Same |
| Biocompatibility (limited contact ( |