(218 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 description and intended use clearly state that it is a surgical mask designed to provide a physical barrier to protect against the transfer of microorganisms, body fluids, and particulate matter, not to treat or cure a disease or condition.
No
The device description clearly states its purpose is to provide a physical barrier to fluids and particulate materials, protecting individuals from the transfer of microorganisms. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly states it is a physical surgical mask made of nonwoven fabric with ear loops and a nose wire, indicating it is a hardware device.
Based on the provided information, 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. This is a physical barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of the mask and its purpose as a barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the physical and barrier properties of the mask (filtration efficiency, fluid resistance, flammability, biocompatibility), not on diagnostic accuracy or analytical performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
The 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 device is intended for Adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
UNIWEB SURGICAL MASK are 3-layer surgical masks that covers and Technology the user's nose and mouth and provides a physical barrier to fluids Characteristics and particulate materials. This device is non-sterile and for single use only. The mask is constructed of nonwoven fabric, including the bottom layer, surface layer and middle layer, and is provided with ear loops and nose wire for individualized fit. Models ASTM Level 1, ASTM Level 2
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
User's nose and mouth
Indicated Patient Age Range
Adult use Only
Intended User / Care Setting
healthcare personnel
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:
- Bacteria Filtration Efficiency (ASTM F2101): 96/96 (3 lots) passed at >= 99% for both Level 1 (>= 95% requirement) and Level 2 (>= 98% requirement).
- Particle Filtration Efficiency (ASTM F2299): 96/96 (3 lots) passed at >= 99% for both Level 1 (>= 95% requirement) and Level 2 (>= 98% requirement).
- Differential Pressure (Delta-P) (EN 14683:2019, Annex C): 96/96 (3 lots) showed 3.6~4.2 H2O/cm², passing at = 70% of control group.
- Skin Sensitization Test (ISO 10993-10): Passed. Acceptance Criteria: Grades =0.
- Skin Irritation Test (ISO 10993-10): Passed. Acceptance Criteria: Mean score 0~0.4 (Negligible).
Shelf-life evaluation: The device maintained its performance in its claimed 3-year shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial Filtration Efficiency: >= 99.8 %
- Particle Filtration Efficiency: 99.74~99.95 % (at 0.1 microgram)
- Differential Pressure: 3.6~4.2 mmH2O/cm²
- Fluid Resistance: Pass at 80 mmHg, Pass 120 mmHg
- Flammability: Class I
- Biocompatibility: Non-Cytotoxic, Non-Sensitizing, Non-Irritating
Predicate Device(s)
K141085 WestTec Procedure Facemask, WestTec Surgical Facemask/ WESTTEC, LLC
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/0 description: The image contains 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.
September 29, 2021
Universal Incorporation % Tyra Chiu Regulatory Consultant VOLER Biotech Consulting Co., Ltd. 1 Ft, No 3-1, Ln. 58, Hejiang St., Zhongshan Dist. Taipei, 72548 Taiwan
Re: K210513
Trade/Device Name: UNIWEB Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 13, 2021 Received: August 31, 2021
Dear Tyra Chiu:
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 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, Ph.D. 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210513
Device Name UNIWEB Surgical Mask
The 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 device is intended for Adult use Only. The UNIWEB Surgical Masks are single use, disposable 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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3
510(k) Summary
Date September 29, 2021
| Manufacturer/ | UNIVERSAL INCORPORATION
10F., No.372 Linsen N. Rd.,Zhongshan Dist.,Taipei City
10446,Taiwan |
|----------------------|---------------------------------------------------------------------------------------------------|
| Contact Person | Mei-Hui Huang
Phone: +886-2-25119161
E-mail: uk@uk.com.tw |
| Device Trade Name | UNIWEB Surgical Mask |
| Common Name | Surgical Masks |
| Classification Name | Masks, Surgical |
| Device Class | II |
| Classification Panel | General & Plastic Surgery |
| Regelation Number | 878.4040 |
| Product Code | FXX |
| Device Description | UNIWEB SURGICAL MASK are 3-layer surgical masks |
that covers and Technology the user's nose and mouth and provides a physical barrier to fluids Characteristics and particulate materials. This device is non-sterile and for single use only. The mask is constructed of nonwoven fabric, including the bottom layer, surface layer and middle layer, and is provided with ear loops and nose wire for individualized fit.
Models ASTM Level 1, ASTM Level 2
- The Surqical Mask is intended to be worn to protect both the Indications for Use patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. This device is intended for adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile.
Predicate Device(s) K141085 WestTec Procedure Facemask, WestTec Surgical Facemask/ WESTTEC, LLC
| Proposed Device | Predicate Device | Comparison | |
|---|---|---|---|
| Device Name | UNIWEB Surgical Mask | WestTec Procedure Facemask, | |
| WestTec Surgical Facemask | - | ||
| 510(k) # | K210513 | K141085 | - |
| Applicant | Universal Incorporation | WESTTEC, LLC | - |
| Product code | FXX (21 CFR 878.4040) | FXX (21 CFR 878.4040) | Same |
| Classification | II | II | Same |
| OTC use | YES | YES | Same |
| Intended Use | The 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 | |||
| device is intended for adult use | |||
| Only. The UNIWEB Surgical | |||
| Masks are single use, | |||
| disposable device, provided | |||
| non-sterile. | WestTec Procedure and | ||
| Surgical facemasks are | |||
| intended to be worn by | |||
| healthcare workers to protect | |||
| the user and patient against | |||
| transfer of microorganisms, | |||
| blood and body fluids, and | |||
| airborne particulates. The | |||
| WestTec Procedure and | |||
| Surgical facemasks are single | |||
| use, disposable devices | |||
| provided non-sterile. | Same | ||
| Dimensions | 175 mm x 95 mm | 175 mm x 90 mm | Similar |
| Layers | Three | Three | Same |
| Mask Style | Flat-pleated | Flat-pleated | Same |
| Design Feature | Ear loops | Ear loops | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| Material: | Surface Layer: Polypropylene | ||
| Spunbond | |||
| Middle Layer: Polypropylene | |||
| Meltblown | |||
| Bottom Layer: Polypropylene | |||
| Spunbond | |||
| Nose Wire: galvanized iron | |||
| wire covered with polyethylene | |||
| Ear Loops: Nylon and Spandex | Outer Layer: spunbond | ||
| polypropylene. | |||
| Middle Layer: meltblown | |||
| polypropylene filter media. | |||
| Inner Layer: spunbond | |||
| polypropylene. | |||
| Earloops are soft non natural | |||
| rubber latex,elastic loops. | |||
| Nose Band: steel wires | |||
| encased in polyethylene | similar | ||
| Fluid Resistance | |||
| (ASTM F1862) | Pass at 80 mmHg, | ||
| Pass 120 mmHg | Pass at 120 mmHg | Same | |
| Bacterial Filtration | |||
| Efficiency (ASTM F2101) | ≥ 99.8 % | 99.7 % | Same. Meet Level 2 |
| requirement | |||
| Differential Pressure | |||
| (Mil-M-36954C) | $3.6{\sim}4.2$ mmH2O/cm² | $3.3{\sim}3.6$ mmH2O/cm² | Same. Meet Level 2 |
| requirement | |||
| Particle Filtration | |||
| Efficiency | |||
| (ASTM F2299) | $99.74{\sim}99.95$ % (at 0.1 | ||
| microgram) | 98 % | Same. Meet Level 2 | |
| requirement | |||
| Flammability | |||
| (16 CFR 1610) | Class I | Class I | Same |
| Biocompatibility | |||
| (ISO 10993-5, -10) | Non-Cytotoxic, Non- | ||
| Sensitizing, Non-Irritating | Non-Cytotoxic, Non- | ||
| Sensitizing, Non-Irritating | Same |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
4
Discussion on Performance Data Non-Clinical Tests
The proposed devices were 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.
5
Non-Clinical Testing Summary:
| Test Methodology | Purpose of the test | F2100-19
Level 1
Requirement | F2100-19
Level 2
Requirement | UNIWEB
Surgical Mask
Test Result
Level 1 | UNIWEB
Surgical Mask
Test Result
Level 2 |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Bacteria Filtration
Efficiency | Determine the bacterial
filtration efficiency as
directed in Test Method
ASTM F2101. | ≥ 95 % | ≥ 98 % | 96/96 (3 lots)
passed at ≥
99% | 96/96 (3 lots)
passed at ≥
99% |
| Particle Filtration
Efficiency | Determine particulate
filtration efficiency as
directed in Test Method
F2299. | ≥ 95 % | ≥ 98 % | 96/96 (3 lots)
passed at ≥
99% | 96/96 (3 lots)
passed at ≥
99% |
| Differential
Pressure (Delta-P) | Determine breathing
resistance or differential
pressure as directed in
EN 14683:2019, Annex
C. |