(470 days)
No
The device description and performance studies focus on the physical properties and filtration capabilities of a disposable surgical mask, with no mention of AI or ML.
No.
This device is a surgical mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
Explanation: The device is a surgical mask intended to protect against the transfer of microorganisms, body fluids, and particulate material. It does not analyze or interpret biological data or images to determine the presence, absence, or status of a disease or condition.
No
The device description clearly states it is a physical surgical mask made of non-woven polypropylene layers, ear loops, and a nose piece. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the mask is for protecting both the surgical patient and operating room 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 and materials of the mask, which are designed for filtration and barrier properties. There is no mention of components or mechanisms for analyzing biological samples or providing diagnostic information.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on the mask's ability to filter particles and fluids, its breathability, and its biocompatibility (cytotoxicity, irritation, sensitization). These are all related to its function as a physical barrier and protective device, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of any components, reagents, software, or processes that would be used to analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical mask does not fit that definition.
N/A
Intended Use / Indications for Use
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G 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. The face masks are single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
The ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond non-woven polypropylene and the middle layer is constructed of melt blown non-woven polypropylene. The mask is held in place over the mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with Galvanized iron wire and allows the user to fit the facemask around their nose. The ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G is sold non-sterile and is intended to be a single use, disposable device.
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
Operating room personnel during 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
Non-clinical testing was completed on 3 nonconsecutive lots of 32 samples for a total of 96 samples of the ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G. The testing evaluated Fluid Resistance Performance (ASTM F1862-17), Bacterial Filtration Efficiency (ASTM F2101-19), Differential Pressure (EN14683:2019 Annex C), Particulate Filtration Efficiency (ASTM F2299-17), Flammability (16 CFR 1610-2008), Cytotoxicity (ISO10993-5), Irritation (ISO10993-10), Sensitization (ISO10993-10), and Performance Testing of Shipping Containers and Systems (ASTM D4169). All samples met the predetermined acceptance criteria for each test.
Key Metrics
- Fluid Resistance Performance: All samples met the predetermined acceptance criteria (At least 29 out of 32 specimens show passing results at 80 mmHg).
- Bacterial Filtration Efficiency: All samples met the predetermined acceptance criteria (>= 95%).
- Differential Pressure (Delta P): All samples met the predetermined acceptance criteria (= 95%).
- Flammability: All samples met the predetermined acceptance criteria (Class I, does not Ignite).
- Cytotoxicity: All samples met the predetermined acceptance criteria (Non-cytotoxic).
- Irritation: All samples met the predetermined acceptance criteria (Non-irritating).
- Sensitization: All samples met the predetermined acceptance criteria (Non-sensitizing).
- Performance Testing of Shipping Containers and Systems: All samples met the predetermined acceptance criteria (No visible damage was found on sample appearance after the test).
Predicate Device(s)
Reference Device(s)
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. To the right of the square is the text "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it in a smaller font.
March 2, 2022
Medtecs (Taiwan) Corp. % Sandy Liu Consultant Jin Services Co. 9F-1, No13, Lane41, Zhangrong Rd, Sec. 5, North District Tainan City, 70447 Taiwan
Re: K203376
Trade/Device Name: ASTM Level 1/EN14683 Type IIR 3-Ply Disposable Surgical Mask, Model number: FM-1400G Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 7, 2022 Received: February 18, 2022
Dear Sandy Liu:
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.
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203376
Device Name
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G
Indications for Use (Describe)
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G 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. The face 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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Image /page/3/Picture/0 description: The image shows the logo for MEDTECS International Corporation Limited. The logo features a stylized human figure in blue and green, with a blue circle representing the head and green shapes forming the body. To the right of the figure, the word "MEDTECS" is written in blue, with the "T" in green. Below "MEDTECS", the words "INTERNATIONAL CORPORATION LIMITED" are written in smaller blue font.
K203376 510(k) Summary As required by 21CFR 807.92 Date of Preparation: 2020.10.30
Applicant Information
| Company Name: | MEDTECS (TAIWAN) CORP. |
|---|---|
| Company Address: | 11F., No. 9, Songgao Road |
| Xinyi Dist., 11073, Taiwan | |
| Telephone: | +886-2-27392222 |
| Fax: | +886-2-27297896 |
| Contact Person: | William Yang |
| Summary Preparation Date: | 2020.10.30 |
Official Correspondent
| Company Name: | Jin Services Co. |
|---|---|
| Company Address: | 9F-1, No13, Lane41, Zhangrong Rd, Sec. 5, North Distrit, Tainan City, Taiwan70447, Taiwan |
| Telephone: | +886-917535026 |
| Email: | contact@fdaclass.com |
| Contact Person: | Sandy Liu, Consultant |
Device Name:
| Trade Name: | ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, |
|---|---|
| Model number: | FM-140G |
| Classification Name: | Surgical Mask |
| Regulation Number: | 878.4040 |
| Product Code: | FXX |
| Device Class: | Class II |
| Panel: | General Hospital |
PREDICATE DEVICE:
K123115, Surgical Face Mask with Ear-Loop, YN-50 JAG Acme Filter Mask Inc.
REFERENCE DEVICE:
K200847, Avianz® Surgical Face Mask
4
Image /page/4/Picture/0 description: The image is a logo for MEDTECS International Corporation Limited. The logo features a green and blue figure on the left, followed by the company name in blue with a green "T". Underneath the company name is the text "INTERNATIONAL CORPORATION LIMITED" in a smaller font. The logo is clean and professional, and the colors are eye-catching.
MEXPO INTERNATIONAL INC. Device Description
The ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond non-woven polypropylene and the middle layer is constructed of melt blown non-woven polypropylene. The mask is held in place over the mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with Galvanized
iron wire and allows the user to fit the facemask around their nose. The ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G is sold non-sterile and is intended to be a single use, disposable device.
Intended Use:
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G 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. The face masks are single use, disposable device, provided non-sterile.
Technological Characteristics Comparison
The following is a summary of the technological characteristics of the ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G as compared to the predicate device.
| Items | Subject Device
ASTM Level 1/EN14683 Type
IIR 3-Ply disposable Surgical
Mask, Model number: FM-
140G | Predicate Device
Surgical Face Mask with Ear-Loop,
YN-50 JAG | Comparison
Result | |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|----------------------|
| Submitter | MEDTECS (TAIWAN) CORP. | Acme Filter Mask Inc. | N/A | |
| 510(k)
Number | N/A | K123115 | N/A | |
| Device
Regulation
number | 878.4040 | 878.4040 | same | |
| Classification | II | II | same | |
| | Subject Device | Predicate Device | | |
| Items | ASTM Level 1/EN14683 Type
IIR 3-Ply disposable Surgical
Mask, Model number: FM-140G | Surgical Face Mask with Ear-Loop,
YN-50 JAG | Comparison
Result | |
| FDA Product
Code | FXX | FXX | same | |
| Indications
for Use | ASTM Level 1/EN14683 Type
IIR 3-Ply disposable Surgical
Mask, Model number: FM-
140G 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. The
face masks are single use,
disposable device, provided
non-sterile. | Surgical Face Mask is Device that is
intended to be worn by operating room
personnel during surgical procedures to
protect both the surgical patient and the
operation room personnel from transfer
of microorganisms, body fluids and
particulate material. | Identical | |
| Prescription
for use | No | No | same | |
| Over the
Counter | Yes | Yes | same | |
| | Design | | | |
| Inner and
Outer Layers | Spun-bond polypropylene | Spun-bond polypropylene | same | |
| Middle Layer | Melt blown polypropylene filter | Melt blown polypropylene filter
Identical | same | |
| Ear loops | not made with natural rubber latex | not made with natural rubber latex | same | |
| Nose Piece | Malleable polyethylene with
Galvanized iron wire | Malleable polyethylene with
aluminum wire | Different | |
| Dimensions | $17.5$ cmL x $9.3$ cm $\pm 0.5$ cm H
( $6.89$ x $3.66\pm 0.2$ inches) | $17.5$ cm L x $9.5$ cm H | Identical | |
| | | Subject Device
ASTM Level 1/EN14683 Type
IIR 3-Ply disposable Surgical
Mask, Model number: FM-
140G | Predicate Device
Surgical Face Mask with Ear-Loop,
YN-50 JAG | Comparison
Result |
| Items | Mask Style | 3 flats pleated | 3 flats pleated | same |
| | Design
Features | Malleable nosepiece, flat
pleated, elastic ear loops | Malleable nosepiece, flat pleated,
elastic ear loops | same |
| | Model size | One-Size (regular) fits all | One-Size (regular) fits all | same |
| | Sterility | Non-sterile | Non-sterile | same |
| | Use | Single Use, Disposable | Single Use, Disposable | same |
| | Color | Green | Green | same |
| | Contain any
drugs or
biologics | No | No | same |
| | face shield
attached | no | no | same |
| | Foam strip
attached | no | no | same |
| | LATEX-
FREE | Yes | Yes | same |
| | | Performance | | |
| | ASTM F2100
Level | Level 1 | Level 1 | same |
| | Fluid
Resistance
Performance | Fluid Resistance | Fluid Resistance | identical |
| | Bacterial
Filtration
Efficiency | Higher than 99% | Higher than 99% | identical |
| | Differential
Pressure
(Delta P) | Avg of 3.1 $mmH_2O/cm^2$ | Average 3.33 ( $mmH_2O/cm^2$ ) | Different |
| | Particulate
Filtration | Avg of 96.14% for 0.1 Sub-micron
Particulate Filtration | Average 94.79% for Solid Aerosol
Filtration Efficiency | Different* |
| Items | Subject Device
ASTM Level 1/EN14683 Type
IIR 3-Ply disposable Surgical Mask, Model number: FM-140G | Predicate Device
Surgical Face Mask with Ear-Loop, YN-50 JAG | Comparison Result | |
| Efficiency | | | | |
| Flammability | Class I (No Flame Spread) | Class I (No Flame Spread) | Identical | |
| Biocompatibility | | | | |
| Cytotoxicity,
ISO10993-5 | Non-cytotoxic | Non-cytotoxic | Identical | |
| Irritation,
ISO10993-10 | Non-irritating | Non-irritating | Identical | |
| Sensitization,
ISO10993-10 | Non-sensitizing | Non-sensitizing | Identical | |
| Labeling, Package and Storage | | | | |
| Storage indication | Store in a dry and well-ventilated environment. Avoid high temperature and keep away from fire and flammable materials. | Store in a dry and well-ventilated environment. Avoid high temperature and keep away from fire and flammable materials. | Identical | |
| Product labeling | All information showing on the Gift box | All information showing on the Gift box | Same | |
| Package materials | Paper un-seal gift box | Paper un-seal gift box | Same | |
| Product package | Paper Gift box (50 pcs/box)
Paper Carton box (40 gift boxes/carton) | Paper Gift box (50 pcs/box)
No information for Carton box | Identical | |
| UDI included on the box | Yes (both gift box and Carton) | No information for UDI | Different | |
| Shelf Life Claim | 5 Years | 5 Years | Same | |
| Item | Standard | Acceptance Criteria
(for Level 1 barrier) | Results | |
| Fluid Resistance
Performance | F2100-19 clause 9.4/ASTM F1862-17:
Standard Test Method for
Resistance of Medical
Face Masks to Penetration
by Synthetic Blood | At least 29 out of 32 specimens show passing
results at 80 mmHg | All samples met the
predetermined acceptance
criteria. | |
| Bacterial
Filtration
Efficiency | F2100-19 clause 9.1/ASTM F2101-19:
Standard Test Method for
Evaluating the Bacterial
Filtration Efficiency
(BFE) of Medical Face | ≥ 95% | All samples met the
predetermined acceptance
criteria. | |
| Item | Standard | Acceptance Criteria
(for Level 1 barrier) | Results | |
| Differential
Pressure (Delta P) | Mask Materials, Using a
Biological Aerosol of
Staphylococcus aureus | | | |
| | F2100-19 clause
9.2/EN14683:2019
Medical Face Masks—
Requirements and Test
Methods Annex C |