X-Y Lubricating Jelly

K220226 · R&R Medical Corporation, Ltd. · NUC · Mar 28, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K220226
• Device Name: X-Y Lubricating Jelly
• Applicant: R&R Medical Corporation, Ltd.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Mar 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

X-Y Lubricating Jelly is a personal lubricant, for vaginal and/or penile 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Story

X-Y Lubricating Jelly is a water-based personal lubricant for over-the-counter use. It is applied topically to vaginal and/or penile tissues to provide moisture and lubrication during sexual activity. The device is packaged in polyethylene tubes. It is intended to enhance comfort and supplement natural body lubrication. The lubricant is compatible with natural rubber latex and polyisoprene condoms but is not compatible with polyurethane condoms. It is a non-sterile product used by consumers in a home/private setting. The device does not involve electronic processing, algorithms, or clinical decision-making software; it functions as a physical barrier/lubricant to reduce friction.

Clinical Evidence

Bench testing only. No clinical data. Performance supported by biocompatibility testing (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity per ISO 10993), shelf-life stability testing, and condom compatibility testing per ASTM D7661-18.

Technological Characteristics

Water-based lubricant; ingredients: water, glycerin, hydroxyethylcellulose, methylparaben. Form factor: 35g/100g polyethylene tubes. Non-sterile. Tested per USP <791> (pH 6.0-7.0), USP <785> (osmolality 200-900 mOsm/Kg), USP <912> (viscosity 600-900 cPs), USP <51> (antimicrobial effectiveness), and USP <61>/<62> (microbial limits).

Indications for Use

Indicated for individuals requiring personal lubrication for vaginal and/or penile application to enhance comfort during sexual activity and supplement natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with polyurethane condoms.

Regulatory Classification

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

• OneTouch™ Lubricant Gel (K142790)

Submission Summary (Full Text)

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March 28, 2023

R&R Medical Corporation Ltd. % Kao Chih Hao Vice President Voler Biotech Consulting CO., Ltd. No. 3-1, Lane 58, Hejiang St., Zhongshan Disy. Taipei City Taiwan

Re: K220226 Trade/Device Name: X-Y Lubricating Jelly Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 17, 2023 Received: February 21, 2023

Dear Kao Chih Hao:

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 (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 located 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.

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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael T. Bailey -S

For Monica 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

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# Indications for Use

510(k) Number (if known) K220226

Device Name X-Y Lubricating Jelly

Indications for Use (Describe)

X-Y Lubricating Jelly is a personal lubricant, for vaginal and/or penile 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 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)

| <input type="checkbox"/> Residential Use (Part 31, SEPP 33) - Select One | <input checked="true" type="checkbox"/> Care-Taker Quarters (31, SEPP 33) - Select One |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------|

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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# K220226 Page 1 of 5

# 510(k) SUMMARY

# K220226 X-Y Lubricating Jelly

| 510(k) Owner: | R&R Medical Corporation Ltd. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Street Address: | No. 4, Ln. 38, Zhongxing N. St., Sanchong Dist., New Taipei City 24158<br>Taiwan (R.O.C.) |
| Contact Person: | Wilson Chang |
| Contact Email: | [e-mail] |
| Contact Number: | Tel: [phone] |
| Summary Preparation Date: | March 24, 2023 |
| Trade Name: | X-Y Lubricating Jelly |
| Common Name: | Personal Lubricant |
| Device Classification: | Regulation Name: Condom<br>Regulation Number: 21 CFR 884.5300<br>Product Code: NUC (lubricant, personal)<br>Device Class: Class II |
| Predicate Device: | OneTouch™ Lubricant Gel<br>510(k) Number: K142790<br>Manufacturer: Thai Nippon Rubber Industry Co., Ltd.<br>Product Code: NUC<br>Device Class: Class II |

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

#### Device Description:

X-Y Lubricating Jelly is a non-sterile, water-based personal lubricant compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The lubricant formulation consists of water, glycerin, hydroxyethylcellulose, and methylparaben. X-Y Lubricating Jelly is packaged in 35 g and 100 g polyethylene tubes with a flip-top closure. The tube is then packaged in a carton. X-Y Lubricating Jelly is a personal lubricant for over-the-counter (OTC) use.

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The device specifications are listed in the tables below:

| Property | Specification |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance, color | Clear colorless |
| Odor | Odorless |
| pH per USP<791> | 6.0-7.0 |
| Osmolality per USP<785> | 200-900 mOsm/Kg |
| Viscosity per <USP 912> | 600-900 cPs |
| Antimicrobial effectiveness per<br>USP <51> | Bacteria: NLT 2.0 log reduction from the initial count at 14<br>days, and no increase from 14 days 'count at 28 days;<br>Yeasts/Molds: No increase from the initial calculated count at<br>14 and 28 days. |
| Total aerobic microbial count<br>(TAMC) per USP<61> | < 100 cfu/g |
| Total yeast and mold count<br>(TYMC) per method equivalent<br>to USP<61> | < 10 cfu/g |
| Presence of Pathogens per<br>USP<62> | Specification |
| Bile-tolerant gram-negative<br>bacteria | Absent/g |
| Pseudomonas aeruginosa | Absent/g |
| Staphylococcus aureus | Absent/g |
| Salmonella | Absent/g |
| Escherichia coli | Absent/g |
| Clostridia | Absent/g |
| Candida albicans | Absent/g |

Table 1: X-Y Lubricating Jelly Device Specifications

#### Indications for Use Statements:

X-Y Lubricating Jelly is a personal lubricant, for vaginal and/or penile 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

#### Comparison of Intended Use and Technological Characteristics to the Predicate Device:

In the table below, the predicate for X-Y Lubricating Jelly is OneTouch Lubricant Gel.

| Feature | X-Y Lubricating Jelly<br>K220226 | OneTouch Lubricant Gel<br>K142790 | Comments |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | X-Y Lubricating Jelly is a personal<br>lubricant, for vaginal and/or<br>penile application, intended to<br>moisturize and lubricant, to<br>enhance ease and comfort of<br>intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is | OneTouch Lubricant Gel is a<br>personal lubricant, for penile<br>and/or vaginal application,<br>intended to moisturize and<br>lubricant, to enhance ease and<br>comfort of intimate sexual activity<br>and supplement the body's natural<br>lubrication. This product is | The indications for use<br>statements for the<br>subject and predicate<br>devices are nearly<br>identical, with the same<br>intended use. |

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| | compatible with natural rubber<br>latex and polyisoprene condoms.<br>This product is not compatible<br>with polyurethane condoms. | compatible with natural rubber<br>latex and polyisoprene condoms.<br>This product is not compatible<br>with polyurethane condoms. | | | | | |
|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|------------------------------------------------|----------------------------------------------------------------------------------------------|
| Base Type | Water | Water | Same: The subject<br>device and predicate<br>device have the same<br>base type. | | | | |
| Shelf-life | 3 years | 3 years | Same: The subject<br>device and predicate<br>device have the same<br>shelf-life. | | | | |
| Primary Ingredients | Water, Glycerin,<br>Hydroxyethylcellulose,<br>Methylparaben | Water, Hydroxyethylcellulose,<br>Glycerin, Methylparaben,<br>Propylparaben, Cremophor | Differences in<br>formulations do not<br>raise different<br>questions of safety and<br>effectiveness (S&E). | | | | |
| Over the counter<br>use | Yes | Yes | Same: The subject<br>device and predicate<br>device are for OTC use. | | | | |
| Sterile | No | No | Same: The subject<br>device and predicate<br>device are non-sterile. | | | | |
| Condom<br>compatibility | Compatible with natural rubber<br>latex and polyisoprene condoms.<br>Not compatible with<br>polyurethane condoms. | Compatible with natural rubber<br>latex and polyisoprene condoms.<br>Not compatible with polyurethane<br>condoms. | Same: The subject<br>device and predicate<br>device have the same<br>condom compatibility. | | | | |
| Biocompatibility<br>Tested | Yes | Yes | Same: The subject<br>device and predicate<br>device were tested and<br>shown to be<br>biocompatible. | | | | |
| Antimicrobial<br>Tested | Yes | Unknown | Unknown: Potential<br>differences in methods<br>determining<br>preservative<br>effectiveness do not<br>raise different<br>questions of S&E. | | | | |
| Microbial Tested<br>(Total aerobic<br>microbial count,<br>total yeast and mold<br>count, absence of<br>pathogens) | Yes | Yes | Same: The subject<br>device and predicate<br>device completed this<br>testing. | | | | |
| pH Tested | Yes | Unknown | Unknown: Potential<br>differences in pH do<br>not raise different<br>questions of S&E. | | | | |
| Osmolality Tested | Yes | Unknown | Unknown: Potential<br>differences in<br>osmolality do not raise<br>different questions of<br>S&E. | | | | |
| Viscosity Tested | Shelf-life | Yes | 3 years | Unknown | 3 years | Unknown: Potential<br>differences in viscosity | differences in viscosity<br>do not raise different<br>questions of S&E.<br>Same: The subject |

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| | | device and predicate<br>device have the same<br>shelf-life. |
|--|--|-------------------------------------------------------------|
| | | |

As stated in the table, the indications for use for the subject and predicate device are nearly identical. Therefore, the subject and predicate devices have the same intended use.

The subject and predicate devices have different technological characteristics. For example, different formulations. The different technological characteristics identified in the table do not raise different questions of safety and effectiveness.

### Summary of Performance Data:

# Biocompatibility

Biocompatibility studies, including cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity testing were performed in accordance with the 2020 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", as follows:

- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)

The results of this testing demonstrated that the subject lubricant is biocompatible.

# Shelf-Life:

The subject device has a shelf-life of 3 years.

The shelf-life duration for the subject device is based on the results of real-time testing. All specifications listed in Table 1 were met throughout the shelf-life duration.

# Condom Compatibility:

The compatibility of the subject device was evaluated in accordance with ASTM D7661-18 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." X-Y Lubricating Jelly was determined to be compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms.

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# Conclusion:

The results of the performance testing described above demonstrate that X-Y Lubricating Jelly is as safe and effective as the predicate device and support a determination of substantial equivalence.