← Product Code [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX) · K252830 # Disposable Surgical Face Mask (3P00B, C2900) (K252830) _Beatles Medical Supplies (Xiantao) Co., Ltd. · FXX · Jan 12, 2026 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K252830 ## Device Facts - **Applicant:** Beatles Medical Supplies (Xiantao) Co., Ltd. - **Product Code:** [FXX](/submissions/SU/subpart-e%E2%80%94surgical-devices/FXX.md) - **Decision Date:** Jan 12, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Indications for Use The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring of microorganisms, body fluids and particulate material. These surgical 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(s), provided non-sterile. ## Device Story Disposable surgical face masks (Models 3P00B, C2900) designed to protect patients and healthcare personnel from microorganisms, body fluids, and particulates. 3P00B is a three-layer mask; C2900 is a four-layer mask. Both feature flat-pleated construction, aluminum nose pieces, and polyester/spandex ear loops. Used in clinical settings for infection control. Masks act as physical barriers to reduce exposure to blood and body fluids. Healthcare providers wear masks during procedures to prevent cross-contamination. Benefits include reduced risk of pathogen transmission and fluid exposure. ## Clinical Evidence No clinical data. Bench testing only. Performance verified via ASTM F2101 (BFE ≥ 99.9%), ASTM F2100 (Differential Pressure < 29.4 mmH2O), ASTM F1862 (Fluid resistance 120-160 mmHg), and 16 CFR 1610 (Flammability Class 1). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10. ## Technological Characteristics Three-layer (3P00B) or four-layer (C2900) flat-pleated masks. Materials: Spun-bonded non-woven fabric, Polyethylene melt-blown non-woven, PE film. Aluminum nose piece. Polyester/spandex ear loops. ASTM F2100-25 Level 2/3 performance. Non-sterile, single-use. No software or electronic components. ## Regulatory 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 - Disposable Surgical Face Mask ([K220597](/device/K220597.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION January 12, 2026 Beatles Medical Supplies (Xiantao) Co., Ltd. % Kiwi Xu Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Bldg., 1500# Century Ave. Shanghai, China Re: K252830 Trade/Device Name: Disposable Surgical Face Mask (3P00B, C2900) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 10, 2025 Received: December 10, 2025 Dear Kiwi Xu: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K252830 - Kiwi Xu Page 2 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- {2} K252830 - Kiwi Xu Page 3 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, ![img-0.jpeg](img-0.jpeg) 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 {3} 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) K252830 | | | Device Name Disposable Surgical Face Mask (3P00B, C2900) | | | Indications for Use (Describe) The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring of microorganisms, body fluids and particulate material. These surgical 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(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." | | {4} K252830 Beatles medical supplies (Xiantao) Co., Ltd. Louhe Industrial Park, Louhe Town, Xiantao City, China # 510(K) Summary # K252830 (As requirement by 21 CFR 807.92) Date prepared: 5th, January, 2026 ## A. Applicant: Name: Beatles medical supplies (Xiantao) Co., Ltd Address: Louhe Industrial Park, Louhe Town, Xiantao City, China Contact: Paul Stark Email: juan@beatles-medical.com Title: Head of Quality Department Submission Correspondent: Primary contact: Ms. Kiwi Xu Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: weijia.xu@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 ## B. Device: Trade Name: Disposable Surgical Face Mask (3P00B, C2900) Name: Surgical Mask Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel ## C. Predicate device: K220597 Disposable Surgical Face Mask Qingdao Bestex Rubber & Plastic Products Co., Ltd. ## D. Indications for use of the device: The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare {5} K252830 # Beatles medical supplies (Xiantao) Co., Ltd. Louhe Industrial Park, Louhe Town, Xiantao City, China personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are 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 subject Disposable Surgical Face Masks has two models, that is Model: 3P00B, ASTM F2100 Level 2 and Model: C2900, ASTM F2100 Level 3. The Disposable Surgical Face Masks (Model: 3P00B, Level 2) are three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, middle layer and outer layer. The colorant is blue master batch. The inner layer and outer layer of 3P00B mask are made of spun-bond non-woven fabric, the middle layer is made of Polyethylene Melt-blown non-woven fabric. The Disposable Surgical Face Masks (Model: C2900, Level 3) are four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, second layer, filtration layer and outer layer. The colorant is blue master batch. The inner layer and outer layer of C2900 are made of spun-bonded non-woven fabric, the second layer is made of Polyethylene PE film, the filtration layer is made of Polyethylene Melt-blown non-woven fabric. The ear loops of both models are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made with Polyester and spandex. The aluminum nose piece in the layers of face mask is to allow the user to form the mask around their nose. The Disposable Surgical Face Masks of both models are sold non-sterile and are intended to be single use, disposable devices. # F. Summary of Technological Characteristics Table 1 Comparison of Subject and Predicate Devices | Device | Subject Device | Predicate Device | Result | | --- | --- | --- | --- | | 510K # | K252830 | K220597 | - | | Manufacturer | Beatles medical supplies (Xiantao) Co., Ltd. | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | - | | Product Name | Disposable Surgical Face Mask (3P00B, C2900) | Disposable Surgical Face Mask | Similar | | Level | ASTM F2100-25 Level 2 and Level 3 | ASTM F2100-19 Level 2 and Level 3 | Similar | | Product Code | FXX | FXX | Same | | Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | | Indications For Use | The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel | The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel | Same | {6} K252830 Beatles medical supplies (Xiantao) Co., Ltd. Louhe Industrial Park, Louhe Town, Xiantao City, China | | from transfer of microorganisms, body fluids and particulate material. These surgical masks are 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. | healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are 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. | | | --- | --- | --- | --- | | Design Feature | Level 2 (3P00B): Ear loop Level 3 (C2900): Ear loop | Level 2: Ear loop Level 3: Ear loop | Similar | | Color | Blue | Blue | Same | | Dimension | 17.5cm×9.5cm | 17.5cm×9.5cm | Same | | Sterility | Non-sterile | Non-sterile | Same | | Use | Single Use, Disposable | Single Use, Disposable | Same | | Particulate filtration efficiency | Level 2: average 98.85% Level 3: average 98.84% | Level 2: average 98.43% Level 3: average 98.56% | Different | | Bacterial filtration efficiency | Level 2: average 99.9% Level 3: average 99.9% | Level 2: average 99.9% Level 3: average 99.9% | Same | | Differential pressure | Level 2: average 17.92 mmH₂O Level 3: average 22.19 mmH₂O | Level 2: average 3.45 mmH₂O/cm² Level 3: average 3.65 mmH₂O/cm² | Different | | Flammability | Class 1 | Class 1 | Same | | Device | Subject Device | Predicate Device | Result | | Fluid resistance | Level 2: Pass at 120mmHg Level 3: Pass at 160mmHg | Level 2: Pass at 120mmHg Level 3: Pass at 160mmHg | Same | | Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | Material | | | | | Outer layer | Spun-bonded non-woven fabric | Spun-bond polypropylene | Different | | Middle layer | Level 2: Polyethylene Melt-blown non-woven fabric Level 3: Second layer: Polyethylene PE film Filter layer: Polyethylene Melt-blown nonwoven fabric | Level 2: Meltblown Polypropylene Filter Level 3: Second layer: PE film Filter layer: Meltblown Polypropylene Filter | Different | | Inner layer | Spun-bond non-woven fabric | Spun-bond polypropylene | Different | | Nose wire | Aluminum | Aluminum | Same | | Ear loops | Polyester and spandex | Nylon and spandex | Different | | Biocompatibility Testing | | | | | Cytotoxicity | Non-cytotoxic under conditions of testing | Non-cytotoxic under conditions of testing | Same | {7} K252830 Beatles medical supplies (Xiantao) Co., Ltd. Louhe Industrial Park, Louhe Town, Xiantao City, China | Skin Irritation | Non-irritating under conditions of testing | Non-irritating under conditions of testing | Same | | --- | --- | --- | --- | | Skin Sensitization | Non-sensitizing under conditions of testing | Non-sensitizing under conditions of testing | Same | | Shelf Life | No shelf life is claimed | No shelf life is claimed | Same | # Difference Analysis: 1. The test reports and evaluation use the ASTM F2100-25 performance criteria instead of the currently recognized ASTM F2100-23 criteria. The evaluation is similar, with the exception that the current differential pressure measurement is adjusted by a factor of $4.9~\mathrm{cm}^2$ , the area of the test sample. Therefore, the F2100-25 criterion of $29.4~\mathrm{mmH_2O}$ is identical to the F2100-23 criterion of $6~\mathrm{mmH_2O/cm^2}$ . The use of either measure is acceptable. 2. The subject device has different material of nose wire and ear loop to the predicate device. However, biocompatibility test has been performed on the subject device and the results does not show any adverse effect. The subject device has different layers and material of the mask body to the predicate device, but the masks has been tested and the test results shown that the mask meet the requirements of the medical mask. # G. Summary of Non-Clinical Testing Non-clinical tests were conducted to verify that the subject device met all design specification. The test results demonstrated that the subject 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: ISO 10993-05 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity ISO 10993-10 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And 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 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 F3502, 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 | Testing | Test method | Acceptance Criteria | Result | | --- | --- | --- | --- | | Bacterial Filtration Efficiency (BFE) | ASTM F2101 | ≥ 98% | Pass | | Differential Pressure (Delta P) | ASTM F2100 | < 29.4 mm H2O (<6.0 mm H2O/cm2) | Pass | {8} K252830 Beatles medical supplies (Xiantao) Co., Ltd. Louhe Industrial Park, Louhe Town, Xiantao City, China | Sub-Micron Particulate Filtration | ASTM F2100 | ≥ 98% at 0.1 micron | Pass | | --- | --- | --- | --- | | Resistance to Penetration by Synthetic Blood | ASTM F1862 | 3P00B: Resistance at 120 mmHg C2900: Resistance at 160 mmHg | Pass | | Flammability | 16 CFR Part 1610 | Class 1 | Pass | | Biocompatibility - Cytotoxicity | ISO 10993-5 | Non-cytotoxic under the conditions of the testing | Pass | | Biocompatibility - Sensitization | ISO 10993-10 | Non-sensitizing under the conditions of the testing | Pass | | Biocompatibility - Irritation | ISO 10993-10 | Non-irritating under the conditions of the testing | Pass | ## H. Clinical Test Conclusion No clinical study is included in this submission. ## I. Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Disposable Surgical Face Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K220597. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K252830](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FXX/K252830) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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