← Product Code [NUC](/productcode/NUC) · K261909 # Plum Vagiceuticals™ Vaginal Moisturizing Suppositories (K261909) _PCCA, Inc. · NUC · Jul 6, 2026 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K261909 ## Device Facts - **Applicant:** PCCA, Inc. - **Product Code:** [NUC](/productcode/NUC.md) - **Decision Date:** Jul 6, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.5300 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology - **Attributes:** Therapeutic, 3rd-Party Reviewed ## Indications for Use Plum Vagiceuticals™ Vaginal Moisturizing Suppositories are a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. ## Device Story Plum Vagiceuticals™ are non-hormonal, glyceride-based vaginal suppositories for OTC use. Device consists of 1.8g solid, off-white suppositories containing 1% sodium hyaluronate, lipid excipients, and mucoadhesive agents. Upon intravaginal insertion, suppository melts at body temperature (30°C-37°C); viscous lipid matrix disperses over mucosal surface. In presence of vaginal fluid, formulation undergoes self-emulsification to form a viscous emulsion that adheres to mucosa, providing lubrication and alleviating dryness. Cleared naturally by gravity and vaginal self-cleaning mechanisms. Intended to enhance comfort during intimate sexual activity. Not compatible with natural rubber latex, polyurethane, or polyisoprene condoms. ## Clinical Evidence Bench testing only. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), vaginal irritation (ISO 10993-23), and acute systemic toxicity (ISO 10993-11). Results confirmed device is non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic. Shelf-life validated via accelerated aging per ASTM F1980-16. ## Technological Characteristics Glyceride-based suppository; 1.8g weight; 1% sodium hyaluronate content. Melting point 30°C-37°C. Disintegration time ≤ 30 minutes. Osmolality 100-300 mOsm/kg. Packaged in PVC/PE blisters. Non-sterile. Testing standards: USP <785>, USP <741>, USP <1112>, USP <61>, USP <62>, Eu.Ph 2.9.2, ASTM F1980-16. ## Regulatory Identification A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility. ## Special Controls *Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document. ## Predicate Devices - Revaree Plus Vaginal Suppositories ([K213220](/device/K213220.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} [LOGO] FDA U.S. FOOD & DRUG ADMINISTRATION July 6, 2026 PCCA, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 1887 Whitney Mesa Dr. Suite 1960 Henderson, Nevada 89014 Re: K261909 Trade/Device Name: Plum Vagiceuticals™ Vaginal Moisturizing Suppositories Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Received: June 8, 2026 Dear Dave Yungvirt: 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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (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} K261909 - Dave Yungvirt 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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 {2} K261909 - Dave Yungvirt Page 3 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, VASUDHA C. SHUKLA -S For Monica D. Garcia, 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 {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. 510(k) Number (if known) K261909 Device Name Plum Vagiceuticals™ Vaginal Moisturizing Suppositories Indications for Use (Describe) Plum Vagiceuticals™ Vaginal Moisturizing Suppositories are a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. 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." FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} PCCA, Inc K261909 Page 1 of 6 Plum Vagiceuticals™ Vaginal Moisturizing Suppositories ### 510(k) Summary ### Plum Vagiceuticals™ Vaginal Moisturizing Suppositories ### K261909 ### I. General Information Submitter/Owner: PCCA 9901 South Wilcrest Drive Houston, Texas, 77099 United States Contact Person: Daniel Banov Vice President of Research and Development PCCA Phone: 832-295-4426 Email: DBanov@pccarx.com July 6, 2026 Preparation Date: ### II. Device Information Trade Name: Plum Vagiceuticals™ Vaginal Moisturizing Suppositories Common Name: Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC (Lubricant, Personal) ### III. Predicate Device Revaree Plus Vaginal Suppositories (K213220) The predicate device has not been subject to a design-related recall. Page 1 {5} K261909 Page 2 of 6 PCCA, Inc Plum Vagiceuticals™ Vaginal Moisturizing Suppositories #### IV. Device Description Plum Vagiceuticals™ Vaginal Moisturizing Suppositories are non-hormonal, non-sterile, glyceride-based personal lubricant, designed for over-the-counter use to alleviate vaginal dryness, enhance comfort during intimate activity, and support the body's natural lubrication. The suppositories are solid, off-white, 1.8 g each, and the shape is designed for easy intravaginal administration. Each vaginal suppository is individually packaged in a polyvinyl chloride (PVC) /polyethylene (PE) blister and marketed in cartons containing 10 vaginal suppositories (two blister packs of 5 vaginal suppositories each). Each vaginal suppository contains 1% sodium hyaluronate in combination with lipid excipients, self-emulsifying agent, and additional hydrating and mucoadhesive agents. The suppositories do not contain hormones or pharmacologically active drug substances. Upon insertion into the vaginal cavity, the suppository melts at body temperature. The viscous lipid matrix disperses over the mucosal surface and provides lubrication in a dry environment. In the presence of vaginal fluid, the formulation undergoes self-emulsification, forming a viscous emulsion. The emulsion system remains in contact with the vaginal mucosa for the intended period of action and is ultimately cleared by gravity and the natural self-cleaning mechanisms of the vagina. The specifications for Plum Vagiceuticals™ Vaginal Moisturizing Suppositories are provided in Table 1. Page 2 {6} K261909 Page 3 of 6 PCCA, Inc Plum Vagiceuticals™ Vaginal Moisturizing Suppositories Table 1. Device specifications | Parameter | Test Method | Specification | | --- | --- | --- | | Appearance | Visual | Solid | | Color | Visual | White to off-white | | Odor | Organoleptic | Practically odorless | | Osmolality | USP <785> Osmolality/ after dilution | 100-300 mOsm/kg (after taking account of dilution factor of 1:10) | | Disintegration Time | Eu.Ph 2.9.2 | ≤ 30 minutes | | Melting Point | USP <741> Class III | 30°C - 37°C | | Water Activity | USP <1112> | < 0.600 | | Average Weight | Gravimetry | 1.8 g | | Content of Sodium Hyaluronate | HPLC | 10 mg/g | | TAMC | USP <61> | ≤ 100 cfu/g | | TYMC | USP <61> | ≤ 10 cfu/g | | Pseudomonas Aeruginosa, Staphylococcus Aureus, Candida Albicans | USP <62> | Absent /g | ### V. Indications for Use Plum Vagiceuticals™ Vaginal Moisturizing Suppositories are a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. ### VI. Substantial Equivalence Discussion A comparison of the intended use and key technological characteristics of the subject and predicate device is provided in Table 2 below. Page 3 {7} K261909 Page 4 of 6 PCCA, Inc Plum Vagiceuticals™ Vaginal Moisturizing Suppositories Table 2. Intended Use and Technological Characteristics of Subject Device Compared to Predicate Device | | Plum VagiceuticalsTM Vaginal Moisturizing Suppositories | Revaree Plus Vaginal Suppositories (K213220) | Comparison | | --- | --- | --- | --- | | Indications for Use | Plum VagiceuticalsTM Vaginal Moisturizing Suppositories are a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. | Revaree plus vaginal suppositories are a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. | Similar | | Over the counter | Yes | Yes | Same | | Base type | Fat-based | Glyceride | Similar | | Ingredients | Hard fat, stearoyl polyoxyl-32 glycerides, polyoxyl 20 cetostearyl ether, sodium hyaluronate, Hippophae Rhamnoides Fruit Oil, sodium polyglutamate, sh-polypeptide-123, tocopheryl acetate, zinc hydrolyzed hyaluronate | HA, glycerides, and sweet almond oil | Different | | Appearance | Off-white opaque vaginal suppositories | Off-white opaque vaginal suppositories | Same | | Average Weight | 1.8 g | 2 g | Different | Page 4 {8} K261909 Page 5 of 6 PCCA, Inc Plum Vagiceuticals™ Vaginal Moisturizing Suppositories | TAMC | ≤100 cfu/g | ≤100 cfu/g | Same | | --- | --- | --- | --- | | TYMC | ≤10 cfu/g | ≤10 cfu/g | Same | | Absence of Pseudomonas Aeruginosa, Staphylococcus Aureus, Candida Albicans | Absent/g | Absent/g | Same | | Condom Compatibility | Not compatible with natural rubber latex, polyisoprene, and polyurethane condoms | Not compatible with natural rubber latex, polyisoprene, and polyurethane condoms | Same | | Packaging | PVC/PE blister of 5 vaginal suppositories | PVC/PE blister of 3 or 5 vaginal suppositories | Same | The subject and predicate device have the similar indications for use and have the same intended use – to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different formulations and device specifications. The different technological characteristics do not raise different questions of safety and effectiveness. ### VII. Summary of Non-Clinical Performance Data # Biocompatibility Biocompatibility testing on the subject lubricant was performed in accordance with the 2023 FDA guidance document Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process” and ISO 10993-1:2018 as follows: - Cytotoxicity (ISO 10993-5:2009) - Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2021) - Vaginal Irritation (ISO 10993-12: 2021; ISO 10993-23: 2021) - Acute Systemic Toxicity (ISO 10993-11:2017) Page 5 {9} K261909 Page 6 of 6 PCCA, Inc Plum Vagiceuticals™ Vaginal Moisturizing Suppositories The results of this testing demonstrate that the subject device is non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic. # Shelf-Life The shelf-life of Plum Vagiceuticals™ Vaginal Moisturizing Suppositories is 12 months. This is based on the results of an intermediate accelerated aging study conducted at 30°C in accordance with ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. # Condom Compatibility Condom compatibility testing was not conducted for the subject device. Therefore, Plum Vagiceuticals™ Vaginal Moisturizing Suppositories are not compatible with natural rubber latex, polyisoprene, and polyurethane condoms # VIII. Conclusions The results of the testing described above demonstrate that Plum Vagiceuticals™ Vaginal Moisturizing Suppositories are as safe and effective as the predicate device and supports a determination of substantial equivalence. Page 6 --- **Source:** [https://fda-staging.innolitics.com/device/K261909](https://fda-staging.innolitics.com/device/K261909) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com