(177 days)
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 is a surgical mask intended to prevent the transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
The device description indicates that it is a "Single Use Surgical Mask" worn to protect from the transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.
No
The device is a physical surgical mask made of fabric layers and earloops, with no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Function: The description clearly states the device is a "Single Use Surgical Mask" intended to be worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier device used on the body, not for testing samples from the body.
- Intended Use: The intended use is for protection during healthcare procedures, not for diagnostic testing.
- Device Description: The description details the physical construction of the mask (layers of polypropylene, earloops), which is consistent with a barrier device, not a diagnostic test kit or instrument.
- Performance Studies: The performance studies listed (Fluid Resistance, Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility) are all relevant to the physical and protective properties of a mask, not to the accuracy or reliability of a diagnostic test.
Therefore, based on the provided information, the Single Use Surgical Mask is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Single Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single use device provided non-sterile.
Product codes
FXX
Device Description
The Single-Use Surgical Mask is a 3-ply, disposable surgical face mask. The outer and inner layers of the mask are made of spunbond polypropylene, while the middle layer consists of a meltblown polypropylene filter fabric. The device is secured on the user's face via elastic earloops and are labeled non-sterile, single-use, and disposable. This device is a surface device intended to come in contact with intact skin for a duration of less than 24 hours.
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
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
| Item/Test Method | Purpose | Criteria | Result |
|---|---|---|---|
| Fluid Resistance (mmHg) (ASTM 1862) | Demonstrate resistance to fluid spray | Pass at 80 mmHg (level 1 fluid resistance) | Pass |
| Bacterial Filtration Efficiency (%) (ASTM F2101-19) | Demonstrate resistance to bacterial penetration | Pass at >= 99% | Pass |
| Particulate Filtration Efficiency (%) (ASTM F2299) | Demonstrate resistance to penetration of particulate matter | Pass at >= 95% | Pass |
| Differential Pressure (EN 14683) | Demonstrate breathability | Pass at |
§ 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 2, 2021
Taiwan Seafood and Fish Corporation Eric Ly Business Development Assistant 733 Gladys Avenue Los Angeles, California 90021
Re: K211773
Trade/Device Name: Single-use Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 26, 2021 Received: September 1, 2021
Dear Eric Ly:
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
1
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,
For 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211773
Device Name Single-Use Surgical Mask
Indications for Use (Describe)
The Single Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single use device 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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1. Submitter Information
Submitted by:
Date Prepared:
Contact Person:
2. Subject Device
Proprietary Name: Common Name: Classification Name and Reference: Device Product Code, Device Panel:
3. Predicate Device
- Predicate Device 510(k) Number: Submitter: Proprietary Name: Device Product Code: Regulation:
4. Device Description
The Single-Use Surgical Mask is a 3-ply, disposable surgical face mask. The outer and inner layers of the mask are made of spunbond polypropylene, while the middle layer consists of a meltblown polypropylene filter fabric. The device is secured on the user's face via elastic earloops and are labeled non-sterile, single-use, and disposable. This device is a surface device intended to come in contact with intact skin for a duration of less than 24 hours.
5. Indications for Use
The Single Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single use device provided non-sterile.
The Indications for Use statement for the Single-Use Surgical Mask is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the protection of both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
6. Comparison of Technological Characteristics
Taiwan Seafood and Fish Corporation 733 Gladys Avenue Los Angeles, CA 90021 213-624-2927
11/18/2021
Eric Ly Business Development Assistant erickltsf@gmail.com
Single-Use Surgical Mask Surgical Face Mask 21 CFR 878.4040, Class II FXX, General Hospital
K202824 Blackbriar Regulatory Services, LLC BRS Procedure Face Mask FXX 21 CFR 878.4040
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The Single-Use Surgical Mask is made of an outer layer consisting of spunbond polypropylene fabric, a middle layer of meltblown polypropylene filter, an inner layer of spunbond polypropylene, 2 earloops made out of nylon and spandex, and a polyethylene nose wire. The technological characteristics of this device are similar to the predicate device because the materials are similar or identical.
| Item | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(k) Number | K211773 | K202824 | - |
| Trade Name | Single-Use Surgical Mask | BRS Procedure Face Mask | - |
| Indications For | |||
| Use | The Single Use Surgical Mask is | ||
| intended to be worn to protect | |||
| both the patient and | |||
| healthcare personnel from the | |||
| transfer of microorganisms, | |||
| body fluids, and particulate | |||
| material. This is a single use | |||
| device provided non-sterile. | BRS Procedure Face Mask is a non- | ||
| sterile, single use, disposable face mask | |||
| intended to be worn to protect both | |||
| healthcare personnel and patients from | |||
| the transfer of microorganisms, blood | |||
| and body fluids, and particulate material. | |||
| This equipment is intended for the use in | |||
| infection control practices to reduce the | |||
| potential exposure to blood and fluids. | |||
| BRS Level 1 Procedure Face Mask | |||
| (Model# 00850021617004) | Similar | ||
| Materials | Outer Layer: Spunbond | ||
| polypropylene | |||
| Middle Layer: Meltblown | |||
| polypropylene filter Inner | |||
| Layer: Spunbond | |||
| Polypropylene | |||
| Earloop: Spandex and Nylon | |||
| Nose piece: Polyethylene wire | Outer Layer: Spunbond polypropylene | ||
| Middle Layer: Meltblown polypropylene | |||
| filter Inner Layer: Spunbond | |||
| polypropylene | |||
| Earloop: Spandex and Nylon | |||
| Nosepiece: iron wire covered in plastic | Similar | ||
| Mask Style | 3-ply, disposable, non-sterile | 3-ply, disposable, nonsterile | Same |
| Mask Dimensions | 175mm x 95mm | 175mm x 95mm | Same |
| ASTM F2100 Level | Level 1 | Level 1 variant | Similar |
| Biocompatibility | |||
| (ISO 10993-5, 10) | Under the conditions of study, | ||
| non-cytotoxic, non-irritating, | |||
| and non-sensitizing | Under the conditions of study, non- | ||
| cytotoxic, non-irritating, and non- | |||
| sensitizing | Same |
The subject device meets the same ASTM F2100 requirements as the ASTM F2100 Level 1 variant of the predicate device.
7. Summary of Nonclinical Testing
| Item/Test Method | Purpose | Criteria | Result |
|---|---|---|---|
| Fluid Resistance | |||
| (mmHg) | |||
| (ASTM 1862) | Demonstrate resistance to fluid spray | Pass at 80 mmHg (level 1 fluid resistance) | Pass |
| Bacterial Filtration Efficiency (%) | |||
| (ASTM F2101-19) | Demonstrate resistance to bacterial penetration | Pass at $≥$ 99% | Pass |
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| Particulate Filtration
Efficiency (%)
(ASTM F2299) | Demonstrate resistance to
penetration of particulate
matter | Pass at ≥ 95% | Pass |
|-----------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------|------|
| Differential Pressure
(EN 14683) | Demonstrate breathability | Pass at