The unscented menstrual three-piece applicator tampon consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator. The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion.

According to different composition materials, the unscented menstrual three-piece applicator tampon of this submission are divided into 4 categories (Cotton tampon with three piece applicator, Organic cotton tampon with three piece applicator, Viscose tampon with three piece applicator, Viscose +Cotton tampon with three piece applicator).

The Tampon are provided in 4 absorbency: Light (L) (absorbency ≤6g), Regular (R) (6-9g), Super (S) (9-12g) and Super Plus (SP) (12-15g).

Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - K252613

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

September 19, 2025

Unibeauty (Hubei) Technology Co., Ltd.
℅ Doris Chen
Regulatory Affairs Specialist
Shanghai Jiushun Enterprise Management Technology Service Co., Ltd.
Room 1502, BaoAn Buiding, No.800 Dongfang Road
Shanghai, 200122
China

Re: K252613
Trade/Device Name: Unscented menstrual three-piece applicator tampon
Regulation Number: 21 CFR§ 884.5470
Regulation Name: Unscented Menstrual Tampon
Regulatory Class: II
Product Code: HEB
Dated: August 16, 2025
Received: August 19, 2025

Dear Doris Chen:

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.

Page 2

K252613 - Doris Chen
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.

Page 3

K252613 - Doris Chen
Page 3

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,

Reginald K. Avery -S

for Jason R. Roberts, Ph.D.
Assistant Director
DHT3B: Division of Reproductive, Gynecology and Urology Devices
OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K252613

Device Name: Unscented menstrual three-piece applicator tampon

Indications for Use (Describe):
The unscented menstrual three-piece applicator tampons are inserted into the vagina to absorb menstrual discharge.

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

Sponsor: Unibeauty (Hubei) Technology Co.,Ltd.
Subject Device: Unscented menstrual three-piece applicator tampon
K252613
Page 1 of 8

510(k) Summary--K252613

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Summary Prepared Date: September 16, 2025

1. Applicant:

Company Name: Unibeauty (Hubei) Technology Co.,Ltd.
Establishment Registration Number: 3027520366
Address: Building A8,nonwoven small and medium-sized enterprise Industrial Park, PENGCHANG Town, Xiantao City, Hubei Province, China,433018
Phone: +86-728-8220088
Contact Person (including title): Guofeng Ou(Manger)

2. Submission Correspondent:

Contact Person: Doris Chen
Shanghai Jiushun Enterprise Management Technology Service Co., Ltd.
Address: Room 1502,BaoAn Buiding,No.800 Dongfang Road,Shanghai,China.
Tel: +86-21-50931939
Email: doris-chen@isosh.com

3. Subject Device Information:

Common Name: Unscented Menstrual Tampon
Trade Name: Unscented menstrual three-piece applicator tampon
Classification Name: Tampon, Menstrual, Unscented
Product Code: HEB
Regulation Number: 21 CFR 884.5470
Regulation Class: II

4. Predicate Device Information:

Sponsor: Unibeauty (Hubei) Technology Co.,Ltd.
Common Name: Unscented Menstrual Tampon
Trade Name: Unscented Menstrual Tampon

Page 6

Sponsor: Unibeauty (Hubei) Technology Co.,Ltd.
Subject Device: Unscented menstrual three-piece applicator tampon
K252613
Page 2 of 8

510(k) number: K232598
Classification Name: Tampon, Menstrual, Unscented
Product Code: HEB
Regulation Number: 21 CFR 884.5470
Regulation Class: II

The predicate device has not been subject to a design-related recall.

5. Device Description

The Tampon are provided in 4 absorbency: Light (L) (absorbency ≤6g), Regular (R) (6-9g), Super (S) (9-12g) and Super Plus (SP) (12-15g).

Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

6.0 Comparison of Technological Characteristics with the Predicate Device

The following table compares the subject device unscented menstrual three-piece applicator tampon to the predicate devices (K232598) with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

6.1 Comparison Table of Technological Characteristic with the Predicate Device

Page 7

Sponsor: Unibeauty (Hubei) Technology Co.,Ltd.
Subject Device: Unscented menstrual three-piece applicator tampon
K252613
Page 3 of 8

Elements of Comparison	Subject Device	Predicate Device	Comment
Device Trade Name	Unscented menstrual three-piece applicator tampon- Cotton tampon with three piece applicator- Organic cotton tampon with three piece applicator- Viscose tampon with three piece applicator- Viscose +Cotton tampon with three piece applicator	Unscented Menstrual Tampon	--
Manufacturer	Unibeauty (Hubei) Technology Co.,Ltd.	Unibeauty (Hubei) Technology Co.,Ltd.	--
K Number	K252613	K232598	--
Product Code	HEB	HEB	Same
Regulation Number	21 CFR 884.5470	21 CFR 884.5470	Same
Classification	Class II	Class II	Same
Indications for Use	The Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual discharge.	The Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual discharge.	Same
Sterile	No	No	Same
Single-Use	Yes	Yes	Same
Design	Tampon with cylindrical shape and bullet-like tip. Applicator with smooth, rounded tip.	Tampon with cylindrical shape and bullet-like tip. Applicator with smooth, rounded tip.	Same
Unscented/Scented	Unscented	Unscented	Same

Page 8

Sponsor: Unibeauty (Hubei) Technology Co.,Ltd.
Subject Device: Unscented menstrual three-piece applicator tampon
K252613
Page 4 of 8

Elements of Comparison	Subject Device	Predicate Device	Comment
Dimensions Specifications (mm)	Cotton tampon with three piece applicator:Pledget length (Dry): 35±5.0--53±5.0Pledget diameter(Dry): 11.5±1.0--18.0±1.5Total length of the product:118.0±4.0Length of the push rod on product:66±2.0Outside diameter (outer tube): 14.5±1.0--20.15±1.0Organic cotton tampon with three piece applicator:Pledget length (Dry): 35±5.0--53±5.0Pledget diameter (Dry): 11.5±1.0--18.0±1.5Total length of the product:118.0±4.0Length of the push rod on product:66±2Outside diameter (outer tube): 14.5±1.0--20.15±1.0Viscose tampon with three piece applicator:Pledget length (Dry): 35±5.0--53±5.0Pledget diameter (Dry): 11.5±1.0--18.0±1.5Total length of the product:118.0±4.0Length of the push rod on product:66±2Outside diameter (outer tube): 14.5±1.0--20.15±1.0Viscose +Cotton tampon with three piece applicator:Pledget length (Dry): 35±5.0--53±5.0Pledget diameter (Dry): 11.5±1.0--18.0±1.5Total length of the product:118.0±4.0Length of the push rod on product:66±2Outside diameter (outer tube): 14.5±1.0--20.15±1.0	Total length of the Product:122.2±1.5Length of the push rod on product:70±1Outside diameter (outer tube): 14.5±0.2--16.2±0.2	Similar
Weight Specifications(g) (Tampon + applicator)	Cotton: L: 3.60-4.60g, R: 4.20-5.20g, S: 5.70-6.70g, SP: 6.45-7.35gOrganic cotton: L: 3.60-4.60g, R: 4.20-5.20g, S: 5.70-6.70g, SP: 6.45-7.35gViscose: L: 4.10-5.10g, R: 4.60-5.60g, S: 5.50-6.50g, SP: 6.40-7.40gViscose+Cotton: L: 4.00-5.00g, R: 4.70-5.20g, S: 5.50-6.50g, SP: 5.90-6.90g	L: 4.55±0.30gR :5.10±0.30gS :5.90±0.35gSP: 6.45±0.35g	Similar
Absorbent Pledget	Cotton, Organic cotton, Viscose, Viscose+Cotton	Viscose and Cotton	Similar
Overwrap	Cotton, Organic cotton, Spunbond/thermalbonded nonwoven fabric/Cotton, Spunbond/thermalbonded nonwoven fabric/Cotton	PE+PP	Different
Removal string	Cotton/Cotton+PP, Organic cotton/Organic cotton+pp, Cotton/Cotton+PP, Cotton/Cotton+PP	Cotton and Polypropylene	Similar
Applicator	Applicator-inner tube:PP+TPE, Applicator-outer tube:PE	LDPE	Different

Page 9

Sponsor: Unibeauty (Hubei) Technology Co.,Ltd.
Subject Device: Unscented menstrual three-piece applicator tampon
K252613
Page 5 of 8

Elements of Comparison	Subject Device	Predicate Device	Comment
Absorbencies	L:≤6g, R: 6-9g, S: 9-12g, SP: 12-15g	L:≤6g, R: 6-9g, S: 9-12g, SP: 12-15g	Similar
Primary packaging	Paper/PE/PP	individual polymeric wrapper	Different

The subject device has the same indication for use as the predicate device as well as similar technological characteristics. The differences include the material composition and dimensions; however, the differences do not raise different questions of safety and effectiveness.

Note 1: TPE(Thermoplastic Elastomer), PP(polypropylene), PE(Polyethylene)

The subject device and predicate device are similar in their pledget composition and components (tampon and applicator). The subject and predicate device differ in the tampon and applicator materials, as well as the tampon and applicator design.

Page 10

Sponsor: Unibeauty (Hubei) Technology Co.,Ltd.
Subject Device: Unscented Menstrual Tampon
K252613
Page 6 of 8

Note 2: The unscented menstrual three-piece applicator tampon(Cotton tampon with three piece applicator, Organic cotton tampon with three piece applicator, Viscose tampon with three piece applicator, Viscose +Cotton tampon with three piece applicator) have new dimensional and weight specifications as compared to the predicate device. The subject device has an organic cotton absorbent pledget that differs from the predicate's cotton and viscose blended pledget; the organic cotton pledget was cleared in K251033. The plastic applicator version of the device differs in applicator material compared to the predicate. The composition material of the applicator is plastic (Thermoplastic Elastomer, polypropylene, Polyethylene). Other design and material specifications remain identical to predicate device.

7. Substantial Equivalence Discussion

Biocompatibility Assessment

Biocompatibility studies were performed in accordance with the FDA guidance document "Guidance for industry and Food and Drug Administration Staff - Use of International Standard 1S0 10993-1, "Biological Evaluation of Medical Devices - Part 1:Evaluation and testing within a risk management process" issued on September 8,2023.

All tampons used with the applicator introduced in this submission were cleared in the predicate or K251033. Therefore, the biocompatibility for all tampons in this submission are leveraged from K232598 and K251033.

The following assessment were performed on the "Tampon" components of subject device.

No.	FDA recognition number	Standards Development Organization (SDO), Designation Number-Year, and Title
1	2-258	ISO 10993-1: 2018 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
2	2-245	ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
3	2-174	ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
4	2-291	ISO 10993-23:2021 Biological evaluation of medical devices-Part 23: Tests for irritation
5	2-255	IS0 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Applicator

Page 11

Sponsor: Unibeauty (Hubei) Technology Co.,Ltd.
Subject Device: Unscented Menstrual Tampon
K252613
Page 7 of 8

For the applicator made of Plastic (Thermoplastic Elastomer, polypropylene, polyethylene), the material of the subject device and the predicate device applicator is different. Therefore, for the applicator made of Plastic, new biocompatibility testing was conducted, including in vitro cytotoxicity, sensitization, and irritation tests, as seen below.

No.	FDA recognition number	Standards Development Organization (SDO), Designation Number-Year, and Title
1	2-258	ISO 10993-1: 2018 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
2	2-245	ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
3	2-174	ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
4	2-291	ISO 10993-23:2021 Biological evaluation of medical devices-Part 23: Tests for irritation

Result

The test results show that the plastic applicator is non-cytotoxic, non-sensitizing, and a non-irritant.

Microbiology Assessment

Per the FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff", menstrual tampons should demonstrate that the tampon, in its final manufactured form, does not:

enhance the growth of Staphylococcus aureus;
increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1);
alter the growth of normal vaginal microflora.

The cotton, organic cotton, viscose + cotton tampon, and viscose versions of the tampon are composed of the same raw material as devices cleared in K251033 and the predicate (K232598). The microbiology test data from the tampons cleared in the predicate device and K251033 were leveraged to demonstrate the microbiological safety of the tampons used with the applicator introduced in the current submission.

Chemical Residue Assessment

Chemical residue assessment of tampons is conducted in accordance with the recommendations outlined in the guidance document "Menstrual Tampons and Pads: Information for Premarket

Page 12

Sponsor: Unibeauty (Hubei) Technology Co.,Ltd.
Subject Device: Unscented Menstrual Tampon
K252613
Page 8 of 8

Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff" dated July 2005.

The tampons listed as compatible with the subject device applicator are identical to the predicate device (K232598), and K251033. Chemical residue testing of the predicate device and K251033 were leveraged to demonstrate the absence of harmful chemicals in the cotton and viscose versions of this device.

8. Summary Of Verification And Validation

Non-clinical performance testing was performed based on a risk assessment utilizing Failure Mode Effect Analysis (FMEA). Following Quality System processes, required testing was conducted to validate the cumulative modifications made to the subject devices. Based on the risk analysis, there is an identification of the verification and/or validation activities required to comply with 21 CFR 820.30. Performance testing was used for verification and validation activities as noted above.

Verification and validation performance testing included dimensional assessments of the applicator and ejection force testing to demonstrate the device meets specifications after manufacturing.

9. Conclusion

The nonclinical tests demonstrate that the subject device, unscented menstrual three-piece applicator tampon, is as safe and effective as the legally marketed predicate device (K232598). Therefore, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.5470 Unscented menstrual tampon.

(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).