(78 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a disposable face mask, with no mention of AI or ML.
No.
The device acts as a barrier to prevent the transfer of microorganisms and particulate material, which is a protective function rather than a therapeutic one.
No
Explanation: The device description clearly states "The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material." It outlines its protective function, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions.
No
The device description clearly outlines physical components (spun-bond polypropylene, melt blown polypropylene, iron core, nylon, spandex) and performance testing related to material properties and physical barriers, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
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 by being worn on the face. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical barrier properties of the mask (filtration efficiency, resistance to penetration, flammability) and biocompatibility. These are relevant to a medical device worn on the body, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
In summary, the Disposable Medical Face Mask functions as a physical barrier for protection, which is the purpose of a medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
Product codes
FXX
Device Description
The Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner (3rd layer) and outer (1st layers are made of spun-bond polypropylene, the middle (2nd layer) is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex.
Each mask contains ear loops to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex.
The Disposable Medical Face Masks are sold and are intended to be single use, disposable devices.
The mask is designed and manufactured in accordance with ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Mask - Premarket Notification [510(K)] Submission issued on March 5, 2004:
- ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks.
- ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- EN 14683, Medical Face Masks- Requirements and Test Methods Annex C;
- ASTM F1862/F 1862M, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at A Known Velocity)
- 16 CFR 1610, Standard for the Flammability of clothing textiles;
- ASTM F3502, Standard Specification for Barrier Face Coverings.
Biocompatibility of patient-contacting material: The biocompatibility of the subject device was determined via the evaluation according to the ISO 10993-5: 2009 and ISO 10993-10:2010 standards.
Key results:
- Bacterial Filtration Efficiency (ASTM F2101): Passed. 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 0923: ≥95%; Lot 1023: ≥95%; Lot 1123: ≥95%.
- Differential Pressure (mmH2O/cm²) (EN 14683:2019 Annex C): Passed. 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 0923:
§ 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.
April 18, 2024
Makrite Industries, Inc. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai. 200122 China
Re: K240258
Trade/Device Name: Disposable Medical Face Mask (M643BE) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: January 31, 2024 Received: January 31, 2024
Dear Ivy Wang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Disposable Medical Face Mask (M643BE)
Indications for Use (Describe)
The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), 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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4
510(K) Summary
K240258
(As required by 21 CFR 807.92)
Date prepared: April 9, 2024
A. Applicant:
Name: MAKRITE INDUSTRIES INC. Address: 11F-5., NO.79, Sec.1, Xintai 5th Rd., XiZhi Dist., New Taipei City 221, Taiwan Contact Person: Bob Wen Tel: +886-2-26982419 Fax: +886-2-26982423 Email: bobwen@makrite.com.tw
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda(@sungoglobal.com
B. Device:
Trade Name: Disposable Medical Face Mask Common Name: Disposable Medical Face Mask Model: M643BE
Regulatory Information Classification Name: Surgical Mask Classification: Class II Product code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel
C. Identification of Primary Predicate device: K22809
Anqing Mayfield Medical Limited. Trade/Device Name: Medical Disposable Face Masks
5
Regulatory Information Classification Name: Surgical Mask Classification: Class II Product code: FXX Regulation Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel
D. Indications for use:
The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
E. Device Description:
The Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner (3rd layer) and outer (1st layers are made of spun-bond polypropylene, the middle (2nd layer) is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex.
Each mask contains ear loops to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex.
The Disposable Medical Face Masks are sold and are intended to be single use, disposable devices.
The mask is designed and manufactured in accordance with ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks.
F. Comparison of technological characteristics with the predicate device
Provided below table 1 is a comparison of the proposed device with the predicate device.
| Table 1 Comparison of Proposed and Predicate Devices | |||
|---|---|---|---|
| Comparison between proposed device and predicate device | |||
| Comparison Items | proposed device | Predicate Device | Result |
| Device Name | Disposable Medical Face Mask | Medical Disposable Face Masks | Similar |
| 510k Number | K240258 | K222809 | --- |
| Product Code | FXX | FXX | Same |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Regulatory Class | Class II | Class II | Same |
| able 1 Comparison of Proposed and Predicate Devices | ||
|---|---|---|
| -- | -- | ----------------------------------------------------- |
6
| | Indications for Use | The Disposable Medical Face
Mask is intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids and particulate
material. The Disposable
Medical Face Mask is intended
for use in infection control
practices to reduce the
potential exposure to blood
and body fluids. This a single
use, disposable device(s),
provided non-sterile. | The Medical Disposable Face
Mask is intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids and particulate
material. The face mask is
intended for use in infection
control practices to reduce the
potential exposure to blood and
body fluids. This is a single
use, disposable device,
provided nonsterile. | Similar | |
|--------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--|
| Size
specification
(Dimension) | | 175×95mm | 17.5×9.5cm
14.5×9.5cm | Similar | |
| Color | | Blue | Blue | Same | |
| Design Feature | | Ear Loops, Flat-pleated, 3 layers | Ear Loops, Flat-pleated, 3 layers | Same | |
| Use | | Single Use, Disposable | Single Use, Disposable | Same | |
| Materials | Outer layer | Spun-bond polypropylene | Spunbond Polypropylene | Same | |
| | Inner layer | Spun-bond polypropylene | Spunbond Polypropylene | Same | |
| | Middle layer
(Filter layer) | Melt blown polypropylene filter | Melt-blown Polypropylene | Same | |
| | Nose piece | Iron core coated with polypropylene | Aluminum with Polypropylene
(PP) covering | Different.
The proposed device
has different material
of nose piece and ear
loop to the predicate
device. | |
| | Ear loop | Nylon, Spandex | Polyester, Spandex | | |
| OTC use | | Yes | Yes | Same | |
| Sterility | | Non-Sterile | Non-Sterile | Same | |
| | ASTM F2100 Level | ASTM F2100-23 Level 1 | ASTM F2100-19 Level 1 | Similar | |
| Fluid
Performance | Resistance | 32 out of 32 per lot pass at 80 mmHg 3 non-consecutive lots tested | 32 out of 32 per lot pass at 80 mmHg 3 non-consecutive lots tested | Same | |
| | ASTM F1862 | | tested | tested | |
7
| Particulate Filtration
Efficiency | ≥ 80%
ASTM F3502-2022a 8.1 | ≥ 95%
ASTM F2299 | Similar. Both masks
meet the particulate
filtration efficiency
requirements for their
respective versions of
ASTM F2100 |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Bacterial Filtration
Efficiency
ASTM F2101 | ≥ 95% | ≥ 95% | Same |
| Differential
Pressure
(Delta P)
EN14683 Annex C | Performance testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Mask - Premarket Notification [510(K)] Submission issued on March 5, 2004:
· ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks.
· ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
· EN 14683, Medical Face Masks- Requirements and Test Methods Annex C;
8
• ASTM F1862/F 1862M, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at A Known Velocity)
- · 16 CFR 1610, Standard for the Flammability of clothing textiles;
· ASTM F3502, Standard Specification for Barrier Face Coverings.
Performance testing are summarized in below table 2.
| Test Methodology | Purpose | Acceptance Criteria
for Level 3 Barrier | Result |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bacterial Filtration
Efficiency
ASTM F2101 | Measure bacterial
filtration efficiency | ≥95% | Passed
3 non-consecutive lots tested, using a
sample size of 32/lot
Lot 0923: ≥95%
Lot 1023: ≥95%
Lot 1123: ≥95% |
| Differential Pressure
(mmH2O/cm²)
EN 14683:2019
Annex C | Determine
breathability of the
mask | > Biocompatibility of patient-contacting material
The biocompatibility of the subject device was determined via the evaluation according to the ISO 10993-5: 2009 and ISO 10993-10:2010 standards.
H. Summary of Clinical Testing
No clinical study is included in this submission.
I. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device in this 510(K) submission, the Disposable Medical Face Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K222809.