(23 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No
The device, a surgical face mask, is intended to protect against the transfer of microorganisms, body fluids, and airborne particles, which is a preventive function rather than a therapeutic one (treatment or cure of a disease).
No
Explanation: The device, a surgical face mask, is intended to protect against the transfer of microorganisms, body fluids, and airborne particles. It does not collect or analyze any physiological data to diagnose a condition.
No
The device description clearly outlines physical components (layers of polypropylene, ear loops, nose piece) and performance studies focus on material properties and physical filtration, not software functionality.
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 individuals from the transfer of microorganisms, body fluids, and airborne particles. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of a surgical face mask, which is a physical barrier.
- Performance Studies: The performance studies focus on the physical and filtration properties of the mask (fluid resistance, filtration efficiency, breathability, flammability), and biocompatibility. These are relevant to a barrier device, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Predicate Device: The predicate device is listed as "Mask, Surgical Apparel," which is consistent with a non-IVD device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non sterile and for single use only.
Product codes
FXX
Device Description
The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.
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 workers
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)
Non-clinical tests were performed on the proposed device.
- Fluid Resistance: 30 out of 32 pass at 120 mmHg (Acceptance Criteria: 29 out of 32 pass at 120 mmHg) - Result: Pass
- Particulate Filtration Efficiency: 99.9% (Acceptance Criteria: ≥ 98%) - Result: Pass
- Bacterial Filtration Efficiency: > 99.9% (Acceptance Criteria: ≥ 98%) - Result: Pass
- Differential Pressure (Delta P): 3.0 mmH20/cm² (Acceptance Criteria:
§ 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 shows 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.
April 23, 2020
Mexpo International Inc. Tim Thai President 2828 Faber Street Union City, California 94587
Re: K200847
Trade/Device Name: Avianz® Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 2, 2020 Received: April 6, 2020
Dear Mr. Thai:
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,
CAPT Elizabeth Claverie, MS 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)
Device Name
Avianz® Surgical Face Mask
Indications for Use (Describe)
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non sterile and for single use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510K SUMMARY
Date of Summary Prepared: April 20, 2020
510K Number: K200847
- Applicant : MEXPO INTERNATIONAL INC. Address : 2828 Faber Street, Union City, CA 94587, U.S.A. Tel : 510 — 489 6800 : 510 - 489 3111 Fax E-mail : mexpoglove@aol.com
Official Correspondence: Tim Thai (President)
2. Device Name: Avianz® Surgical Face Mask
3. Regulatory Information
| Classification Name | : Surgical Face Mask, Apparel |
|---|---|
| Classification | : Class II |
| Product Code | : FXX |
| Regulation Number | : 21 CFR 878.4040 |
4. Predicate Device
| 510K Number | : K911334 - Thai Hospital Products Co. Ltd |
|---|---|
| Device Name | : Mask, Surgical Apparel |
5. Intended Use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
6. Device Description
The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.
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7. Summary of Comparison and Technological Characteristics
Table 1 - General Comparison
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| Manufacturer | MEXPO INTERNATIONAL | ||
| INC. | Thai Hospital Products Co. Ltd. | - | |
| 510K Number | K200847 | K911334 | - |
| Product Common | |||
| Name | SURGICAL FACE MASK | SURGICAL FACE MASK | Same |
| Product Code | FXX | FXX | Same |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same |
| Intended Use | When properly worn, the | ||
| surgical face masks are | |||
| intended to protect both | |||
| patient and healthcare | |||
| workers from transfer of | |||
| microorganisms, body fluids | |||
| and airborne particles. This | |||
| device is non-sterile and for | |||
| single use only. | When properly worn, the | ||
| surgical face masks are | |||
| intended to protect both patient | |||
| and healthcare workers from | |||
| transfer of microorganisms, | |||
| body fluids and airborne | |||
| particles. This device is non- | |||
| sterile and for single use only. | Same | ||
| Model | 3 Ply, Ear Loops, Flat-Pleated | ||
| Style | 3 Ply, Ear Loops or Tie-On | Similar |
| Materials | |||
|---|---|---|---|
| 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 |
| Nose Piece | Single Galvanize Wire, Coated | ||
| By PE | Single Galvanize Wire, Coated By | ||
| PE | Same | ||
| Ear Loops | not made with natural rubber latex | not made with natural rubber latex | Same |
| Color | White | Blue, Pink, Yellow, Green, | |
| Orange, Purple, White & Multi | |||
| Color | Similar | ||
| Dimension (Width) | $9.0cm \pm 0.5cm$ | $9.0cm \pm 0.5cm$ | Same |
| Dimension | |||
| (Length) | $17.5cm \pm 0.5cm$ | $17.5cm \pm 0.5cm$ | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100 Level | Level 2 | Level 2 | Same |
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8. Non-clinical Tests Performed on the Proposed Device
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 5, 2004.
Table 2 - Performance Testing
| Item | Proposed Device | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid | |||
| Resistance | |||
| Performance | |||
| ASTM F1862 | 30 Out of 32 pass at 120 | ||
| mmHg | 29 Out of 32 pass at 120 | ||
| mmHg | Pass | ||
| Particulate | |||
| Filtration | |||
| Efficiency | |||
| ASTM F2299 | 99.9% | ≥ 98% | Pass |
| Bacterial | |||
| Filtration | |||
| Efficiency | |||
| ASTM F2101 | > 99.9% | ≥ 98% | Pass |
| Differential | |||
| Pressure | |||
| (Delta P) MIL- | |||
| M-36954C | 3.0 mmH20/cm² |