(136 days)
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 is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Face Mask is single use, three-layer, 3-pleated or 4-pleated flat-folded masks with nose piece and ear loops or ties. The masks will be provided in blue or black color with option for a visor. The colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner and outer layers are made of spun-bond polypropylene, the 2nd layer is made of melt blown polypropylene. The only difference between Level 1, Level 2, and Level 3 masks is the material density in the middle layer. The nose piece is made of Iron wire covered with polypropylene plastic, ear loop is made of elastic band, the ties are made of spun-bond polypropylene, and the visor is made of polyethylene terephthalate (PET).
Each mask contains ear loops or ties 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 non-sterile and are intended to be single use, disposable devices.
N/A
FDA 510(k) Clearance Letter - K252650
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
January 5, 2026
Makrite Industries, Inc.
℅ Ivy Wang
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Century Ave.
Shanghai,
China
Re: K252650
Trade/Device Name: Disposable Medical Face Mask
Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical Apparel
Regulatory Class: Class II
Product Code: FXX
Dated: December 22, 2025
Received: December 22, 2025
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.
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K252650 - Ivy Wang
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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" (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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K252650 - Ivy Wang
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assistance/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,
BIFENG QIAN -S
Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K252650
Device Name: Disposable Medical Face Mask
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 is 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(K) Summary - K252650
(As required by 21 CFR 807.92)
Date prepared: 11/06/2025
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 Surgical Mask
Classification Name: Surgical Face Mask
Classification: Class II
Product code: FXX
Regulation Number: 21 CFR 878.4040
Review Panel: Surgical Apparel
510(k) number: K252650
C. Identification of Primary Predicate device:
K202903
SURGICAL FACE MASK
Rizhao Sanqi Medical & Health Articles Co., Ltd.
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
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is a single use, disposable device(s), provided non-sterile.
E. Device Description:
The Disposable Medical Face Mask is single use, three-layer, 3-pleated or 4-pleated flat-folded masks with nose piece and ear loops or ties. The masks will be provided in blue or black color with option for a visor. The colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner and outer layers are made of spun-bond polypropylene, the 2nd layer is made of melt blown polypropylene. The only difference between Level 1, Level 2, and Level 3 masks is the material density in the middle layer. The nose piece is made of Iron wire covered with polypropylene plastic, ear loop is made of elastic band, the ties are made of spun-bond polypropylene, and the visor is made of polyethylene terephthalate (PET).
Each mask contains ear loops or ties 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 non-sterile and are intended to be single use, disposable devices.
Models:
| Mask Style | Three-pleated | Four-pleated | ||
|---|---|---|---|---|
| Ear loops | Tie-on | Ear loops | Tie-on | |
| Level 1 | - | M643BT | S643BE | S643BT |
| Level 1 with visor | M643BEF | M643BTF | S643BEF | S643BTF |
| Level 2 | M653BE, M653KE (black) | M653BT | S653BE, S653KE (black) | S653BT |
| Level 2 with visor | M653BEF, M653KEF (black) | M653BTF | S653BEF, S653KEF (black) | S653BTF |
| Level 3 | - | - | S663BE | S663BT |
| Level 3 with visor | M663BEF | M663BTF | S663BEF | S663BTF |
B-Blue, K-Black, E-earloop, T-Tie-on, F-Visor, M -3 pleated, S-4 pleated
F. Comparison of technological characteristics with the predicate device
The Disposable Medical Face Masks are essentially the same as or similar to the predicate device in terms of the indications for use, design and construction, performance characteristics. 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 | Surgical Face Mask | Different |
| 510k Number | K252650 | K202903 | Different |
| Product Code | FXX | FXX | Same |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Regulatory Class | Class Ⅱ | Class Ⅱ | Same |
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| 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 is a single use, disposable device(s), provided non-sterile. | The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, these face masks are 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 non-sterile. | Same |
|---|---|---|---|
| Size specification (Dimension) | 175×95mm | 175×95mm | Same |
| Color | Blue, Black | Blue, white, pink, green, yellow | Different |
| Design Feature | Ear Loops, Tie-on | Ear Loops, Tie-on | Same |
| Offer with visor | Yes | Yes | Same |
| Mask style | 3 or 4 Flat-pleated, 3 layers | 3 Flat-pleated, 3 or 4 layers | Similar |
| 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 covered with polypropylene | Steel coated by polypropylene | Similar |
| Ear loop | Nylon, Spandex | Spandex | Different |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| ASTM F2100 Level | ASTM F2100-23 Level 1, Level 2, Level 3 | ASTM F2100-19 Level 1, Level 2, Level 3 | Similar |
| Fluid Resistance Performance | Meet ASTM F1862/F1862M24 | Meet ASTM F1862/F1862M17 | Similar |
| Sub-micron particulate filtration efficiency | Meet ASTM F3502-2022a | Meet ASTM F2299-17 | Different |
| Bacterial Filtration Efficiency | Meet ASTM F2101-23 | Meet ASTM F2101-19 | Similar |
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| Differential Pressure (Delta P) | Meet EN 14683: 2019, Annex C | Meet EN 14683: 2019, Annex C | Same |
|---|---|---|---|
| Flammability | Meet 16 CFR 1610 | Meet 16 CFR 1610 | Same |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating | Non-cytotoxic, non-sensitizing, non-irritating | Same |
G. Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specification. 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:
- ISO10993-5 Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
- 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;
- ASTM F1862/F1862M, 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 is summarized in below table 2.
Table 2: Summary of Performance Testing
| Test | Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|---|
| Level 1 | Level 2 | |||
| Bacterial Filtration Efficiency | ASTM F2101 | The purpose of the performance testing is to demonstrate the functionality of the subject device. | ≥95% | ≥ 98% |
| Differential Pressure (mmH2O/cm2) | EN 14683:2019 Annex C | <5.0 mmH2O/cm2 | < 6.0 mmH2O/cm2 | |
| Sub-micron Particulate Filtration Efficiency | ASTM F3502-2022a | ≥80% | ≥85% | |
| Resistance to | 29 out of 32 | 29 out of 32 |
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| Penetration by Synthetic Blood ASTM F1862/F1862M-24 | pass at 80 mmHg | pass at 120 mmHg | pass at 160 mmHg |
|---|---|---|---|
| Flammability 16 CFR Part 1610-2008 | Class I | Class I | Class I |
| Item | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | The purpose of the testing is to demonstrate the safety of the subject device. | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| Irritation | Non-Irritating | Under the conditions of the study, the device is non-irritating. | |
| Sensitization | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing |
H. Summary of Clinical Testing
No clinical study is included in this submission.
I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates 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 K202903.
§ 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.