← Product Code [NUC](/productcode/NUC) · K260068 # pjur NATURE Touch, 100 ml (K260068) _Pjur Group Luxembourg S.A. · NUC · May 21, 2026 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260068 ## Device Facts - **Applicant:** Pjur Group Luxembourg S.A. - **Product Code:** [NUC](/productcode/NUC.md) - **Decision Date:** May 21, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.5300 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use pjur® NATURE Touch, 100 ml is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms ## Device Story Non-sterile, water-based personal lubricant; applied topically to penile, vaginal, or anal areas to reduce friction and enhance comfort during sexual activity. Formulation includes water, glycerin, xanthan gum, and botanical extracts. Provided in 100 ml HD-PE/LD-PE bottles. Used by consumers in home settings. Output is physical lubrication; assists in maintaining comfort and preventing condom breakage (latex/polyisoprene). ## Clinical Evidence Bench testing only. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-11 (acute systemic toxicity), and ISO 10993-23 (vaginal irritation). Condom compatibility tested per ASTM D7661-18. Shelf-life testing confirmed specifications met over 24 months. ## Technological Characteristics Water-based lubricant. Ingredients: aqua, glycerin, xanthan gum, levulinic acid, sodium levulinate, sodium anisate, sodium hydroxide, Tremella Fuciformis Sporocarp Extract. pH 5.20–5.90; viscosity 1,500–5,000 mPa*s; osmolality <600 mOsmol/kg. Packaging: HD-PE/LD-PE bottle. Testing standards: USP <791>, <912>, <841>, <785>, <51>, <61>, <62>; ASTM D7661-18. ## 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 - Wet Organics Personal Lubricant ([K182027](/device/K182027.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 May 21, 2026 Pjur Group Luxembourg S.A. Andrea Giebel, PRRC Person Responsible for Regulatory Compliance 87, Esplanade De La Moselle Wasserbillig, 6637 Luxembourg Re: K260068 Trade/Device Name: pjur NATURE Touch, 100 ml Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 8, 2025 Received: January 9, 2026 Dear Andrea Giebel: 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} K260068 - Andrea Giebel, PRRC 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 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. {2} K260068 - Andrea Giebel, PRRC 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, Monica D. Garcia -S 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} FORM FDA 3881 (6/20) 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: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K260068 | | | Device Name pjur® NATURE Touch, 100 ml | | | Indications for Use (Describe) pjur® NATURE Touch, 100 ml is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane 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." | | {4} pjur group 510(k) Summary – K260068 K260068 Page 1 of 5 1. Applicant: Company Name: pjur group Luxembourg Company Address: 87, Esplanade de la Moselle L-6637 Wasserbillig, Luxembourg Contact Number: Telephone: +(352) 74-8989 Fax: +(352) 74-8990 Mail: info@pjur.com Contact Person: Andrea Giebel, PRRC E-Mail: andreagiebel@pjur.com Summary Preparation Date: May 20, 2026 2. Subject Device Information: Device Trade Name: pjur® NATURE Touch, 100 ml Common Name: Personal lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Product Code: NUC (lubricant, personal) Device Class: II 3. Predicate Device Information: | Predicate 510(k) Number | K182027 | | --- | --- | | Predicate Trade Name | Wet Organics Personal Lubricant | | Predicate Manufacturer | Trigg Laboratories DBA Wet International | The predicate device has not been subject to a design-related recall. 4. Device Description pjur® NATURE Touch, 100 ml is a non-sterile, water-based personal lubricant. It is not a contraceptive nor a spermicide. The pjur® NATURE Touch, 100 ml is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. pjur® NATURE Touch, 100 ml has a water-based formulation that consists of aqua (water), Glycerin, Xanthan Gum, Levulinic Acid, Sodium Levulinate, Sodium Anisate, Sodium Hydroxide, and Tremella Fuciformis Sporocarp Extract. pjur® NATURE Touch, 100 ml is provided in a 100 ml HD-PE / LD-PE bottle. {5} pjur\* group 510(k) Summary – K260068 K260068 Page 2 of 5 The device specifications for pjur® NATURE Touch, 100 ml are outlined in the table below. | pjur® NATURE Touch, 100 ml Lubricant | | | | --- | --- | --- | | Parameter | Method | Specification | | Appearance | Visual | Clear liquid | | Odor | Olfactory | Odorless | | pH value | USP<791> | 5.20 – 5.90 | | Viscosity | USP<912> | 1,500 – 5,000 mPa*s | | Density | USP <841> | 0.900 – 1,200 g/mL | | Osmolality | USP<785> | < 600 mOsmol/kg | | Antimicrobial Effectiveness | USP<51> | Meets USP <51> acceptance criteria for Category 2. Bacteria: No less than 2.0 log reduction from initial count at 14 days, and no increase from the 14-day count at 28 days. Yeast and Molds: No increase from the initial calculated count at 14 days and 28 days. | | Total Aerobic Microbial Count (TAMC) | USP<61> | <100 cfu/g | | Total Yeast and Mold Count (TYMC) | USP<61> | <10 cfu/g | | Presence of pathogenic organisms | USP<62> | Absence of: Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans and Aspergillus brasiliensis | # 5. Indication for Use pjur® NATURE Touch is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. {6} pjur\* group 510(k) Summary – K260068 K260068 Page 3 of 5 # 6. Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Device The table below compares the intended use and technological characteristics of the subject and predicate device. | Parameter | Subject Device pjur®NATURE Touch, 100 ml | Predicate Device Wet Organics Personal Lubricant (K182027) | Comparison | | --- | --- | --- | --- | | Indications for Use | pjur®NATURE Touch, 100 ml is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. | The Wet Organics Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. | Similar | | Rx / OTC | OTC | OTC | Same | | Base Type | Water-based | Water-based | Same | | Primary Ingredients | Aqua (Water), Glycerin, Xanthan Gum, Levulinic Acid, Sodium Levulinate, Sodium Anisate, Sodium Hydroxide, Tremella Fuciformis Sporocarp Extract. | Purified Water Organic aloe barbadensis leaf juice Zemea Select Propanediol Vegeluron Gel Cellosize QP-30000-H Xanthan Gum Sodium Hyaluronate Microcare SB Citric Acid Co Extract Blend | Different | | Appearance | Clear liquid | Clear to slightly cloudy, semi-viscous | Similar | | Odor | Odorless | Odorless (Characteristic) | Same | | Viscosity | 1,500 – 5,000 mPa*s | 1,000 – 2,300 cps | Similar | | pH value | 5.20 – 5.90 | 4.0 - 5.0 | Similar | {7} pjur\* group 510(k) Summary – K260068 K260068 Page 4 of 5 | Parameter | Subject Device pjur®NATURE Touch, 100 ml | Predicate Device Wet Organics Personal Lubricant (K182027) | Comparison | | --- | --- | --- | --- | | Osmolality | <600 mOsm/kg | <1,800 mOsm/kg | Similar | | Microbial Limits | TAMC: <10² KBE/g [cfu/g] TYMC: <10¹ KBE/g [cfu/g] Pathogenic Organisms: Absent | TAMC: <100 cfu/g TYMC: <10 cfu/g Pathogenic Organisms: Absent | Same | | Antimicrobial Effectiveness Testing (USP<51> Category 2) | Meets USP <51> acceptance criteria for Category 2 products | Meets USP <51> acceptance criteria for Category 2 products | Same | | Sterile | No | No | Same | | Biocompatibility | Yes | Yes | Same | | Condom Compatibility | compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms | compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms | Same | | Packaging | HD-PE bottles with a polypropylene cap | polyethylene terephthalate bottle with a dispensing bottle cap with a disc top. | Different | | Shelf Life | 24 months | 12 months | Different | The subject device, pjur® NATURE Touch, 100 ml, and the predicate device, Wet Organics Personal Lubricant (K182027) have similar indications for statements and the same intended use - to moisturize and lubricate and to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The subject and predicate devices have different technological characteristics as shown in the table above, including different appearance, viscosity, pH, osmolality, ingredients and packaging. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. ## 7. Summary of Non-Clinical Testing ### Biocompatibility Biocompatibility testing for the subject device was conducted in accordance with the 2023 FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" as follows: - Cytotoxicity: ISO 10993-5:2009 - Sensitization: ISO 10993-10:2021 - Acute Systemic Toxicity: ISO 10993-11:2017 - Vaginal Irritation: ISO 10993-23:2021 {8} pjur group 510(k) Summary – K260068 K260068 Page 5 of 5 The results of this testing demonstrated that the subject lubricant is non-cytotoxic, non-irritating, nonsensitizing, and not systemically toxic. ## Condom Compatibility The compatibility of the subject devices with condoms was evaluated in accordance with ASTM D7661-18, "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and were determined to be: - compatible with natural rubber latex condoms, - compatible with polyisoprene condoms, - not compatible with polyurethane condoms. ## Shelf-Life The subject device has a 24 month shelf life. Testing on device samples demonstrated that the subject device met all specifications listed in the device specification table across the device shelf life. ## 8. Conclusion The results of the performance testing described above demonstrate that $pjur^{\text{®}}$ NATURE Touch, 100 ml is as safe and effective as the predicate device and supports a determination of substantial equivalence. --- **Source:** [https://fda.innolitics.com/device/K260068](https://fda.innolitics.com/device/K260068) **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