(42 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and barrier performance of a surgical face mask. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The TAIJI Professional Series Level 3 Surgical Face Masks are intended for infection control and protection against fluid and particulate transfer, not for treating or preventing specific medical conditions or restoring bodily functions.
No
Explanation: The device is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.
No
The device description clearly outlines a physical face mask made of multiple layers of nonwoven polypropylene and meltblown fiber, secured with elastic ear loops. The performance studies focus on physical and biological properties of the material, 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 clearly states the mask is for protecting 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 of the mask, which is designed to filter and block substances. It does not describe any components or mechanisms for analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on barrier properties (fluid resistance, filtration efficiency), physical properties (differential pressure, flammability), and biocompatibility (cytotoxicity, irritation, sensitization). These are relevant to a protective barrier device, not an IVD.
In summary, the TAIJI Professional Series Level 3 Surgical Face Mask is a medical device intended for protection and infection control, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The TAIJI Professional Series Level 3 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 fluid. This is a single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
The TAIJI Professional Series Level 3 Surgical Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene).
The mask is a single use, disposable device, provided nonsterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and surgical procedures
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 Testing:
- ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Barrier Testing): Samples met the predetermined acceptance criteria.
- ASTM F2101-19: Standard Specification for Performance of Materials Used in Medical Face Masks (Barrier Testing): Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each).
- EN 14683:2019 Annex C and ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks (Physical Testing): Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each).
- ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks (Barrier Testing): Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each).
- 21 CFR 1610 (Safety Testing): Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each).
- ISO 10993-5: Biological evaluationofmedical devices - Part 5: Tests for in vitro cytotoxicity (Safety Testing): Fail.
- ISO 10993-11: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (Safety Testing): Pass (No systemic toxicity: device is not toxic).
- ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (Safety Testing): Pass.
- ISO 10993-10: Biological evaluationofmedical devices - Part 10: Tests for irritation and skin sensitization (Safety Testing): Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance Performance: Pass at 160 mmHg
- Particulate Filtration Efficiency Performance (%): Pass at ≥98%
- Bacterial Filtration Efficiency Performance (%): Pass at ≥98%
- Differential Pressure (Delta-P) (mm H2O/cm2): Pass at ≤6.0
- Flammability class Class 1: Pass Class 1
- Cytotoxicity: Fail (Under conditions of the study, the device considered is cytotoxic (neat and 1:2 extracts were scored 3))
- Systemic Study / Systemic Injection Test / ISO GLP ISO 10993-11: evaluation of medical devices - Part 11: Tests for systemic toxicity: Pass (No systemic toxicity: device is not toxic)
- Irritation: Under conditions of the study, the device is Non-irritating
- Sensitization: Under conditions of the study, the device is Non-sensitizing
Predicate Device(s)
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.
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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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 28,2021
Taiji Medical Supplies, Inc. % Abdel Halim President, Global and Regulatory Affairs Global Quality and Regulatory Services 10 Scenic Way Monroe, New Jersey 08831
Re: K211861
Trade/Device Name: TAIJI Professional Series Level 3 Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: July 21, 2021 Received: July 23, 2021
Dear Abdel Halim:
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 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 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
2
Indications for Use
510(k) Number (if known) K211861
Device Name
TAIJI Professional Series Level 3 Surgical Face Mask
Indications for Use (Describe)
The TAIJI Professional Series Level 3 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 intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single use, disposable device, provided non-sterile.
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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Image /page/3/Picture/0 description: The image shows the logo for TAJI Medical Supplies. The logo consists of the letters "TMS" in blue, with the words "TAJI Medical Supplies" in a smaller font below. To the right of the letters is a red graphic that looks like two curved lines. The logo is simple and professional, and the colors are eye-catching.
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submissions, Issued March 5, 2004 (corrected July 14, 2004).
1. Device and Company Details:
510(k) Number: K211861
| Submitter / Owner
Taiji Medical Supplies, Inc.
3211 Progress Drive
Lincolnton, NC 28092
T: (828) 310-2802
E: tiffany@taijimedical.com | Contact Person
Ms. Katherine L. Giannamore, Esq.
Shehadeh Giannamore, PLLC
396 Alhambra Circle, Suite 100A
Coral Gables, FL 33134
T: (305) 507-9843
E: katherine@sglawfl.com |
|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation of this Summary: | June 10, 2021 |
| Device Trade or Proprietary Name: | TAIJI Professional Series Level 3 Surgical
Face Mask |
| Device Common/Usual Name: | Surgical Mask |
| Regulation Name/Device Class/
Product Code: | Surgical Apparel/Class II/FXX |
| Predicate Device Name/K Number: | Premier Guard USA 3 Layer Ear Loop
ASTM Level 3 Surgical Face Mask/K202595 |
- Device Description: The TAIJI Professional Series Level 3 Surgical Face Mask is in accordance with the FDA Guidance Document, Surgical Masks - Premarket Notification [510K)] Submissions issued on March 5, 2004. TAIJI Professional Series Level 3 Surgical Face mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene).
The mask is a single use, disposable device, provided nonsterile.
4
Image /page/4/Picture/0 description: The image contains the logo for TAJI Medical Supplies. The logo consists of the letters "TMS" in blue, with the words "TAJI Medical Supplies" in a smaller font below. To the right of the letters are two red curved lines that resemble a stylized heartbeat or wave pattern. The logo is simple and modern, with a clear emphasis on the company's name and medical focus.
Intended Use: The TAIJI Professional Series Level 3 Surgical Face Mask is a non- sterile, single-use, disposable mask, intended to be worn in healthcare and surgical procedures.
3. Technological Characteristics Comparison:
The following is a summary of the technological characteristics of the TAIJI Professional Series Level 3 Surgical Face Mask as compared to the predicate device.
| Items | Subject Device
TAIJI
Professional
Series Level 3
Surgical Face
Mask | Predicate Device
K202595 | Comparison | | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Manufacturer | TAIJI Medical
Supplies, Inc. | Premier Guard
USA, LLC | N/A | | |
| 510(k) Number | K211861 | K202595 | N/A | | |
| FDA Product Code | FXX | FXX | Same | | |
| Indications for Use | The TAIJI
Professional
Series Level 3
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
fluid. This is a
single use,
disposable
device, provided
non-sterile | The Premier
Guard USA 3
Layer Ear Loop
ASTM Level 3
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
fluid. This is a
single use,
disposable device,
provided non-
sterile | Same | | |
| | Inner and Outer
Layers | Spun-bond
polypropylene | Spun-bond
polypropylene | | |
| Materials | Middle Layer | Melt blown
polypropylene
filter | Melt blown
polypropylene
filter | Same | |
| | Ear Loops | Polyester with
Spandex inner-
core | Nylon and
Spandex | Similar | |
| | Nose Piece | Malleable
polyethylene
with aluminum
wire | Polyethylene
laminated soft
annealed carbon
steel wire | Similar | |
| | Dimensions | | 17.5cm length x
9.5cm height | 17.5cm length x
9.5cm height | Same |
| Mask Style | | Flat Pleated | Flat Pleated | Same | |
| Design Features | | Malleable
nosepiece, flat-
pleated elastic
ear loops | Malleable
nosepiece, flat-
pleated elastic ear
loops | Same | |
| Sterility | | Non-sterile | Non-sterile | Same | |
| Use | | Single Use,
Disposable | Single Use,
Disposable | Same | |
| Color | | Blue and White | Blue and White | Same | |
| ASTM F2100 Level | | Level 3 | Level 3 | Same | |
| Biocompatibility | | | | | |
| Cytotoxicity | | Under
conditions of the
study,
the
device
considered is
cytotoxic (neat
and 1:2 extracts
were scored 3) | Under conditions
of the study, the
device is Non-
cytotoxic | Fail -
Acute Systemic
Study was
recommended
by 3PR and
agreed upon by
FDA | |
| | | Systemic Study / Systemic
Injection Test / ISO GLP ISO
10993-11:
evaluation of medical devices
- Part 11: Tests for systemic
toxicity | Under
conditions of the
study,
the
device is non-
cytotoxic | N/A | Pass
No systemic
toxicity: device
is not toxic |
| | | Irritation | | Under
conditions of the
study,
the
device is Non-
irritating | Under conditions
of the study, the
device is Non-
irritating |
| Sensitization | Under
conditions of the
study, the
device is Non-
sensitizing | Under conditions of
the study, the
device is Non-
sensitizing | Same | | |
| Fluid Resistance Performance
(mmHg) | Pass at 160
mmHg | Pass at 160
mmHg | Same | | |
| Particulate Filtration Efficiency
Performance (%) | Pass at ≥98% | Pass at ≥98% | Same | | |
| Bacterial Filtration Efficiency
Performance (%) | Pass at ≥98% | Pass at ≥98% | Same | | |
| Differential Pressure (Delta-
P) (mm H O/cm ) | Pass at ≤6.0 | Pass at