Medical surgical mask
Device Facts
| Record ID | K233723 |
|---|---|
| Device Name | Medical surgical mask |
| Applicant | Guangdong Kingfa Sci. & Tech.Co., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Jul 29, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Intended Use
The medical surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Device Story
Medical surgical mask; flat pleated design with ear loops and nose piece. Three-layer construction: inner/outer layers polypropylene; middle layer melt-blown polypropylene. Nose piece: metallic iron wire coated with polypropylene resin. Used in operating rooms and clinical settings by healthcare personnel. Protects against transfer of microorganisms, blood, body fluids, and particulates. Single-use, disposable. Provides barrier protection; performance meets ASTM F2100 Level 2 standards.
Clinical Evidence
No clinical data. Bench testing only. Performance verified against ASTM F2100-19, ASTM F2101 (BFE >99.9%), ASTM F2299 (PFE 99.73%), ASTM F1862 (synthetic blood penetration at 120 mmHg), and EN 14683 (differential pressure 4.6 mmH2O/cm2). Biocompatibility confirmed via ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Three-layer flat pleated mask. Materials: polypropylene (layers), metallic iron wire/polypropylene resin (nose piece), polyester/polyurethane (ear loops). ASTM F2100 Level 2 performance. Biocompatibility per ISO 10993-5/10. Sterilization: sterile/non-sterile options. No software or electronic components.
Indications for Use
Indicated for operating room personnel and general healthcare workers to protect patients and users against transfer of microorganisms, blood, body fluids, and particulate materials.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) (K202843)
Related Devices
- K202904 — Surgical Face Mask · Jiangxi Feilikang Medical Technology Co., Ltd. · Jan 21, 2021
- K250082 — Procedure mask/Surgical mask/Face mask · Winner Medical Co., Ltd. · Jun 18, 2025
- K202126 — Disposable Surgical Mask · Shenzhen Peninsula Medical Co., Ltd. · Jun 8, 2021
- K210244 — Disposable Medical Face Mask · Suzhou Bolisi Medical Technology Co., Ltd. · Jul 12, 2021
- K211249 — Altor Safety 3-Ply Surgical Mask (Model:62222) · Altor Safety, LLC · Jul 23, 2021
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
July 29, 2024
Guangdong Kingfa Sci. & Tech. Co., LTD.
Xiaoge Yu
Manager
No.28, Delong Ave., Shijiao Town, Qingcheng District
Qingyuan, Guangdong 511545
China
Re: K233723
Trade/Device Name: Medical surgical mask
Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical Apparel
Regulatory Class: Class II
Product Code: FXX
Dated: June 26, 2024
Received: June 27, 2024
Dear Xiaoge Yu:
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K233723 - Xiaoge Yu
Page 2
(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.
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-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,
Allan Guan -S
For Bifeng Qian, M.D., Ph.D
Assistant Director
DHT4C: Division of Infection Control Devices
{2}
K233723 - Xiaoge Yu
Page 3
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
{3}
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.
Submission Number (if known)
K233723
Device Name
Medical surgical mask
Indications for Use (Describe)
The medical surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
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."
{4}
510(k) Summary - K233723
# 510(k) Summary [AS REQUIRED BY 21CFR807.92]
## I. Submitter
GUANGDONG KINGFA SCI. & TECH.CO., LTD.
No. 28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province 511545, China
Contact person: Xiaoge Yu
Position: Manager
Tel.: +86-13570952157
E-mail: yuxiaoge@kingfa.com.cn
Preparation date: July 25, 2024
## II. Proposed Device
Device Trade Name: Medical surgical mask
Common name: Medical surgical mask
Regulation Number: 21 CFR 878.4040
Regulatory Class: Class II
Product code: FXX
Review Panel: General Hospital
## III. Predicate Devices
510(k) Number: K202843
Trade name: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)
Common name: Surgical Face Mask
Classification: Class II
Product Code: FXX
Manufacturer: B.J.ZH.F.Panther Medical Equipment Co., Ltd
## IV. Device description
The medical surgical mask is flat pleated style mask, utilizing ear loops way for wearing, and has nose piece design for fitting the medical surgical mask around the nose.
The medical surgical mask is manufactured with three layers, the inner and outer layers are made of polypropylene, only the outer layers' color is blue, and the middle layer is made of melt blown polypropylene.
Ear loops, which is held to cover the users' mouth and nose by two polypropylene bands ultrasonic welded to the medical surgical mask. The elastic ear loops are not
{5}
510(k) Summary - K233723
made with natural rubber latex.
The nose piece contained in the medical surgical mask is in the middle layer of medical surgical mask to allow the user to fit the medical surgical mask around their noses, which is made of metallic iron wire coated with polypropylene resin.
The dimensions of each medical surgical mask are length $175 \pm 8.75 \mathrm{~mm}$ and width $95 \pm 4.75 \mathrm{~mm}$.
The dimension of nose piece is length $\geq 80\mathrm{mm}$.
The medical surgical mask can be provided in sterile and non-sterile two types, and is intended to be a single use, disposable device.
## V. Indication for use
The medical surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
## VI. Comparison of technological characteristics with the predicate device
Table 1 Comparison of medical surgical mask
2 of 7
{6}
510(k) Summary - K233723
| Item | Proposed device (K233723) | Predicate device (K202843) | Discussion |
| --- | --- | --- | --- |
| Trade name | Medical surgical mask | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) | - |
| Product code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Classification | Class II | Class II | Same |
| Indication for use | The medical surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. | The Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. | Same |
| Mask Style | Ear loop, flat | Ear loop/Tie-on, Flat | Different Note 1 |
| Specification and Dimension | 17.5cmx9.5cm; | 17.5cmx9.5cm; 14.5cmx9cm; | Different Note 1 |
| OTC use | Yes | Yes | Same |
| Sterility | Sterile/Non-sterile | Sterile/Non-sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Shelf life | 3 years | / | Different Note 4 |
| Material | | | |
| Outer facing layer | Polypropylene | Spun-bonded nonwoven polypropylene | Different Note 2 |
3 of 7
{7}
510(k) Summary - K233723
| Middle layer | Polypropylene melt-blown | Melt-blown nonwoven polypropylene | |
| --- | --- | --- | --- |
| Inner facing layer | Polypropylene | Spun-bonded nonwoven polypropylene | |
| Nose clip | Polypropylene and metallic iron | Medical polypropylene and Q235 | |
| Ear loops | Polyester and polyurethane | Nylon and spandex | |
| Design features | Color: blue | Color: blue | Same |
| Product performance | | | |
| Performance Testing (according to ASTM-2100) | Level 2 | Level 2 | Same |
| Bacterial Filtration Efficiency | Average >99.9% | Average 98.92% | Similar Note 3 |
| Differential Pressure | Average 4.6 mmH₂O/cm² | Average 4.4 mmH₂O/cm² | Similar Note 3 |
| Resistance to penetration by synthetic blood | pass at 120 mmHg | pass at 120 mmHg | Same |
| Particulate Filtration Efficiency | Average 99.73% | Average 98.98% | Similar Note 3 |
| Flammability | Class 1 | Class 1 | Same |
4 of 7
{8}
510(k) Summary - K233723
| Biocompatibility | ISO 10993-5 and ISO 10993-10.
Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing, and non-irritating. | ISO 10993-5 and ISO 10993-10.
Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing, and non-irritating. | Same |
| --- | --- | --- | --- |
**Note 1:**
The "Mask style", "Specification and Dimension" of proposed device are covered by the predicate devices. The proposed devices have more "Mask style" and "Specification and Dimension".
**Note 2:**
Although the "Material" of proposed device is different from the predicate devices, non-clinical performance tests and the biocompatibility tests have been performed on the proposed device according to ASTM F2100, ISO 10993-5 and ISO 10993-10. The results do not show any adverse effect.
**Note 3:**
Although the "Bacterial Filtration Efficiency" "Differential Pressure" and "Particulate Filtration Efficiency" of proposed device are different from the predicate devices, all of them meet the requirement of safety and essential performance standard ASTM F2100. Therefore, the differences between the predicate devices and proposed device will not affect the safety and effectiveness of the proposed device.
**Note 4:**
Shelf life is 3 years according to accelerated aging testing conducted for the proposed device. Therefore, this difference will not affect the safety and effectiveness between the proposed device and the predicate device.
**VII. Summary of Non-Clinical Testing**
5 of 7
{9}
510(k) Summary - K233723
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:
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
- ASTM F1862, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- EN 14683, Medical Face Masks - Requirements and Test Methods
- ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus
- ASTM F2299, Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- 16 CFR 1610, Standard for the Flammability of Clothing Textiles
- ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
Table 2 Summary of Non-Clinical Performance Testing
| Test Method | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Bacterial Filtration Efficiency ASTM F2101 | Measure bacterial filtration efficiency | ≥98% | Pass |
| Differential Pressure(mmH2O/cm2) EN14683:2019 Annex C | Determine breathability of the mask | <6.0 mmH2O/cm2 | Pass |
| Sub-micron Particulate Filtration Efficiency ASTM F2299-17 | Measure initial particle filtration efficiency | ≥98% | Pass |
| Resistance to Penetration by Synthetic Blood ASTM F1862-17 | Evaluate the resistance to penetration by impact of small volume of | 29 out of 32 pass at 120 mmHg | Pass |
{10}
510(k) Summary - K233723
| | synthetic blood | | |
| --- | --- | --- | --- |
| Flammability 16 CFR Part 1610-2008 | Response of materials to heat and flame | Class 1 | Pass |
| In vitro Cytotoxicity
ISO 10993-5 | Verify that the proposed device extract is non-cytotoxic. | The extract is non-cytotoxic under the study conditions. | Pass |
| Skin Irritation
ISO 10993-10 | Verify that the proposed device extract is non-irritating. | The polar and non-polar extracts are non-irritating under the study conditions. | Pass |
| Skin Sensitization
ISO 10993-10 | Verify that the proposed device extract is non-sensitizing. | The polar and non-polar extracts are non-sensitizing under the study conditions. | Pass |
## VIII. Clinical Testing
No clinical study is included in this submission.
## IX. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the proposed device in 510(K) submission, the medical surgical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202843.
7 of 7
