Grosz Warming Liquid is intended for penile, vaginal and/or anal application 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, polyisoprene and polyurethane condoms.

Grosz Play Tingling is intended for penile, vaginal and/or anal application 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.

Grosz KY Yours & Mine is intended for penile, vaginal and/or anal application to mosturize 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 Description

Grosz Warming Liquid is a non-sterile, silicone-based personal lubricant compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Its formulation consists of Dimethicone and Sensate. Grosz Warming Liquid is packaged in a 30 mL high density polyethylene bottle (HDPE) mono layer and topped with a polypropylene cap. The bottle is then packaged in a carton. Grosz Warming Liquid is a personal lubricant for over-the-counter (OTC) use.

Grosz Play Tingling is a non-sterile, water-based personal lubricant compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. Its formulation consists of Water, Propylene Glycol, Carbomer, Xanthan Gum, Sensate, Benzoic Acid, Sodium Saccharin, and Sodium Hydroxide. Grosz Play Tingling is packaged in a 50 mL HDPE bottle and topped with a polypropylene cap. The bottle is then packaged in a carton. Grosz Play Tingling is a personal lubricant for OTC use.

Grosz KY Yours & Mine are two personal lubricants with the same formulations and specifications as Grosz Warming Liquid and Grosz Play Tingling, respectively, packaged together and compatible with natural rubber latex and polyisoprene condoms. Grosz KY Yours & Mine is not compatible with polyurethane condoms when used as intended. Grosz KY Yours and Grosz KY Mine are individual lubricants separately packaged in a 44 mL polyethylene terephthalate bottles and topped with a polypropylene cap and packaged together in a carton. Grosz KY Yours & Mine are for OTC use.

AI/ML Overview

The provided text describes information for a 510(k) submission for personal lubricants (Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine). It details the product specifications, comparison to a predicate device, and performance data to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text presents two tables (Table 1 for Grosz Warming Liquid and Grosz KY Yours, Table 2 for Grosz Play Tingling and Grosz KY Mine) listing properties and their corresponding specifications, which serve as acceptance criteria. The performance is reported as meeting these specifications throughout the shelf-life duration.

Table 1: Grosz Warming Liquid and Grosz KY Yours

Property	Specification	Reported Performance (Met throughout shelf-life)
Appearance	Liquid	Met
Color	Clear, Colorless	Met
Odor	Odorless	Met
Viscosity per USP <912>	70-110 cPs	Met
Antimicrobial effectiveness per USP <51>	Bacteria: NLT 2.0 log reduction from the initial count at 14 days, and no increase from 14 days 'count at 28 days; Yeasts/Molds: No increase from the initial calculated count at 14 and 28 days.	Met
Total aerobic microbial count (TAMC) per USP	< 100 cfu/g	Met
Total yeast and mold count (TYMC) per USP	< 10 cfu/g	Met
Presence of Pathogens per EP 8.0 Section:
Pseudomonas aeruginosa	Absent/g	Met
Staphylococcus aureus	Absent/g	Met
Escherichia coli	Absent/g	Met
Candida albicans	Absent/g	Met

Table 2: Grosz Play Tingling and Grosz KY Mine

Property	Specification	Reported Performance (Met throughout shelf-life)
Appearance	Gel	Met
Color	Transparent, Colorless	Met
Odor	Very slightly acidic, no objectionable odor	Met
Viscosity per USP <912>	3,400 - 10,000 cPs	Met
pH per USP <791>	3.5 - 4.5	Met
Osmolality per USP <785>	883-1,200 mOsm/kg	Met
Antimicrobial effectiveness per USP <51>	Bacteria: NLT 3.0 log reduction from the initial count at 7 days, and no increase from 7 days' count at 28 days; Yeasts/Molds: 2.0 log reduction from the initial count at 14 days, and no increase from the 14 days' count at 28 days.	Met
Total aerobic microbial count (TAMC) per USP	< 100 cfu/g	Met
Total yeast and mold count (TYMC) per USP	< 10 cfu/g	Met
Presence of Pathogens per method equivalent
Pseudomonas aeruginosa	Absent/g	Met
Staphylococcus aureus	Absent/g	Met
Escherichia coli	Absent/g	Met
Candida albicans	Absent/g	Met

Study to Prove Device Meets Acceptance Criteria

The document refers to various performance tests conducted to demonstrate that the devices meet the acceptance criteria and are substantially equivalent to the predicate devices. These include:

Biocompatibility Studies: 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.
Shelf-Life Testing: Accelerated aging and real-time testing were conducted for Grosz Warming Liquid and Grosz KY Yours, and accelerated aging testing for Grosz Play Tingling and Grosz KY Mine. All specified properties (from Tables 1 and 2) were met throughout their respective shelf-life durations (15 months for Grosz Warming Liquid, 2 years for the others).
Condom Compatibility Testing: Evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Specific compatibility results are provided for each product.
Microbial Testing: Total aerobic microbial count (TAMC), total yeast and mold count (TYMC), and absence of specific pathogens were tested according to methods equivalent to USP <61> and EP 8.0 Section: 2.6.13 or USP <62>.
Physical/Chemical Properties: Viscosity (per USP <912>), pH (per USP <791>), and Osmolality (per USP <785>) were tested where applicable, with results meeting the specified ranges.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test sets in the performance studies (e.g., number of batches, number of samples per test). It mentions that "the results of this testing demonstrated that the subject lubricants are biocompatible" and "all specifications... were met throughout the shelf-life duration," implying that sufficient samples were tested to support these conclusions.

The provenance (country of origin, retrospective/prospective) of the data is not mentioned. These types of studies for personal lubricants are typically laboratory-based tests on manufactured products, rather than clinical studies involving human subjects for the primary performance criteria listed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" for the performance criteria of these personal lubricants is established by adherence to recognized national and international standards and pharmacopeial monographs (e.g., USP, ISO, ASTM, EP). These tests have objective endpoints (e.g., cfu/g, cPs, pH values, log reduction) that do not typically require expert human interpretation in the same way an imaging or diagnostic device might.

4. Adjudication Method for the Test Set

Not applicable, as expert consensus or adjudication is not typically used for these types of objective laboratory performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a personal lubricant, not an AI-assisted diagnostic or imaging device for which MRMC studies would be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a personal lubricant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance criteria is based on established scientific standards, pharmacopeial monographs, and consensus standards (e.g., USP <912> Viscosity, USP <51> Antimicrobial Effectiveness, ASTM D7661-10 for Condom Compatibility, ISO 10993 for Biocompatibility, EP for Pathogens). These standards define the acceptable ranges or outcomes for each property.

8. The Sample Size for the Training Set

Not applicable. This device is a personal lubricant, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 7, 2023

RB Health (US) LLC Lisa Burns Sr. Manager Regulatory Affairs 399 Interpace Parkway Parsippany, NJ 07054

Re: K213892

Trade/Device Name: Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine Regulation Number: 21 CFR$ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 31, 2023 Received: February 3, 2023

Dear Lisa Burns:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael T. Bailey -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

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Indications for Use

510(k) Number (if known) K213892

Device Name

Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine

Indications for Use (Describe)

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)

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510(k) Summary K213892

Grosz Warming Liquid, Grosz Play Tingling, and Grosz KY Yours & Mine

510(k) Owner:	RB Health (US)
Street Address:	399 Interpace Parkway, Parsippany, NJ 07054-0224
Contact Person:	Lisa Burns
Contact Numbers:	862-325-0012
Summary Preparation Date:	March 1, 2023
Trade Name:	Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
Common Name:	Personal Lubricant
Device Classification:	Regulation Name: CondomRegulation Number: 21 CFR 884.5300Product Code: NUC (lubricant, personal)Device Class: Class II
Predicate Device:	Swiss Navy Premium Silicone Lubricant and Swiss Navy PremiumWater-Based Lubricant510(k) Number: K150153Manufacturer: Package Solutions LLCProduct Code: NUCDevice Class: Class II

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

Device Description:

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bottles and topped with a polypropylene cap and packaged together in a carton. Grosz KY Yours & Mine are for OTC use.

The device specifications are listed in the tables below:

Table 1 Grosz Warming Liquid and Grosz KY Yours

Property	Specification
Appearance	Liquid
Color	Clear, Colorless
Odor	Odorless
Viscosity per <USP 912>	70-110 cPs
Antimicrobial effectiveness per USP <51>	Bacteria: NLT 2.0 log reduction from the initial count at 14 days, and no increase from 14 days 'count at 28 days; Yeasts/Molds: No increase from the initial calculated count at 14 and 28 days.
Total aerobic microbial count (TAMC) per method equivalent to USP<61>	< 100 cfu/g
Total yeast and mold count (TYMC) per method equivalent to USP<61>	< 10 cfu/g
Presence of Pathogens per EP 8.0 Section: 2.6.13	Specification
Pseudomonas aeruginosa	Absent/g
Staphylococcus aureus	Absent/g
Escherichia coli	Absent/g
Candida albicans	Absent/g

Table 2 Grosz Play Tingling and Grosz KY Mine

Property	Specification
Appearance	Gel
Color	Transparent, Colorless
Odor	Very slightly acidic, no objectionable odor
Viscosity per USP <912>	3,400 - 10,000 cPs
pH per USP <791>	3.5 - 4.5
Osmolality per USP<785>	883-1,200 mOsm/kg
Antimicrobialeffectiveness per methodequivalent to USP<51>	Bacteria: NLT 3.0 log reduction from the initial count at 7 days, andno increase from 7 days' count at 28 days; Yeasts/Molds: 2.0 logreduction from the initial count at 14 days, and no increase fromthe 14 days' count at 28 days.
Total aerobic microbialcount (TAMC) permethod equivalent toUSP<61>	< 100 cfu/g

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Total yeast and moldcount (TYMC) permethod equivalent toUSP<61>	< 10 cfu/g
Presence of Pathogensper method equivalentto USP<62>	Specification
Pseudomonas aeruginosa	Absent/g
Staphylococcus aureus	Absent/g
Escherichia coli	Absent/g
Candida albicans	Absent/g

Indications for Use Statements:

Grosz KY Yours & Mine is intended for penile, vaginal and/or anal application 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 Grosz Warming Liquid and Grosz Yours is the Swiss Navy Premium Silicone Lubricant, while the predicate for Grosz Play Tingling and Grosz KY Mine is the Swiss Navy Premium Water Based Lubricant.

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Feature	GroszWarmingLiquidK213892	Grosz PlayTinglingK213892	Grosz KY Yours &MineK213892	Swiss Navy Premium[Silicone Lubricantand Water-BasedLubricant]K150153	Comments
Indications forUse	Grosz WarmingLiquid isintended forpenile, vaginaland/or analapplication tomoisturize andlubricate, toenhance theease andcomfort ofintimate sexualactivity andsupplementthe body'snaturallubrication.This product iscompatiblewith naturalrubber latex,polyisopreneandpolyurethanecondoms.	Grosz Play Tingling isintended for penile,vaginal and/or analapplication tomoisturize andlubricate, toenhance the easeand comfort ofintimate sexualactivity andsupplement thebody's naturallubrication. Thisproduct iscompatible withnatural rubber latexand polyisoprenecondoms. Thisproduct is notcompatible withpolyurethanecondoms.	Grosz KY Yours &Mine is intended forpenile, vaginal and/oranal application tomoisturize andlubricate, to enhancethe ease and comfortof intimate sexualactivity andsupplement thebody's naturallubrication. Thisproduct is compatiblewith natural rubberlatex andpolyisoprenecondoms. Thisproduct is notcompatible withpolyurethanecondoms.	The Swiss NavyPremium Lubricantsare personallubricants for penileand / or vaginalapplication, intendedto moisturize andlubricate, to enhancethe ease and comfortof intimate sexualactivity andsupplement thebody's naturallubrication. Theseproducts arecompatible withnatural rubber latexand polyisoprenecondoms. Theseproducts are notcompatible withpolyurethanecondoms.	The indications foruse statements forthe subject andpredicate devices arenot identical, as thesubject devices arealso indicated for analuse and havedifferences incondomcompatibility. Thesedifferences do notrepresent a newintended use as boththe subject andpredicate devices areintended to providelubrication to anorifice with orwithout use ofcompatible condoms.
Base Type	Silicone	Water	Grosz KY Yours:SiliconeGrosz KY Mine:Water	Silicone Lubricant:SiliconeWater-Based Lubricant:Water	Same: The subjectdevices and theirrespective predicatedevice have the samebase type.
Primaryingredients	Dimethicone,Sensate	Water,PropyleneGlycol,Carbomer,Xanthan Gum,Sensate,Benzoic Acid,SodiumSaccharin,SodiumHydroxide	Grosz KY Yours:Dimethicone, SensateGrosz KY Mine:Water,PropyleneGlycol,Carbomer,Xanthan Gum,Sensate, BenzoicAcid, SodiumSaccharin,SodiumHydroxide	Not available	Differences informulations is notknown between GroszWarming Liquid/GroszKY Yours and the SwissNavy Premium SiliconeLubricant or betweenGrosz Play Tingling/GrosKY Yours and the SwissNavy Premium WaterBased Lubricant.Differences informulations do notraise differentquestions of safety

					and effectiveness(S&E).
Over the counteruse	Yes	Yes	Yes	Yes	Same: The subjectdevices and theirrespective predicatedevice are for OTC use.
Sterile	No	No	No	No	Same: The subjectdevices and theirrespective predicatedevice are non-sterile.
CondomCompatibility	Compatible withnatural rubberlatex andpolyisoprenecondoms andpolyurethanecondoms.	Compatible withnatural rubberlatex andpolyisoprenecondoms. Notcompatible withpolyurethanecondoms.	Compatible withnatural rubber latexand polyisoprenecondoms. Notcompatible withpolyurethanecondoms.	These products arecompatible with naturalrubber latex andpolyisoprene condoms.These products are notcompatible withpolyurethanecondoms.	Different: Condomcompatibility differsbetween the subjectdevices and theirrespective predicatedevice. Differences incondom compatibilitydoes not raise differentquestions of S&E.
BiocompatibilityTested	Yes	Yes	Yes	Yes	Same: The subjectdevices and theirrespective predicatedevice were tested andshown to bebiocompatible.
AntimicrobialTested	Yes	Yes	Yes	Unknown	Differences inantimicrobial testing isnot known betweenGrosz WarmingLiquid/Grosz KY Yoursand the Swiss NavyPremium SiliconeLubricant or betweenGrosz Play Tingling/GroszKY Yours and the SwissNavy Premium WaterBased Lubricant.Differences inantimicrobialtesting do not raisedifferent questionsof safety andeffectiveness (S&E).
Microbial Tested(Total aerobicmicrobial count,total yeast andmold count,absence ofpathogens)	Yes	Yes	Yes	Yes	Same: The subjectdevices and theirrespective predicatedevice completed thistesting.
pH Tested	No	Yes	Grosz KY Yours: No	Silicone Lubricant: No	Same: The subjectdevices and theirrespective predicate
			Grosz KY Mine: Yes	Water-Based Lubricant: Yes	device are the same regarding testing for this parameter.
Osmolality Tested	No	Yes	Grosz KY Yours: No	Silicone Lubricant: No	Same: The subject devices and their respective predicate device are the same regarding testing for this parameter.
Viscosity Tested	Yes	Yes	Yes	Yes	Same: The subject devices and their respective predicate device are the same regarding testing for this parameter.

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As stated in the table, the indications for use for the subject and predicate devices are not identical, as the subject device is for anal, vaginal, and penile use, while the predicate device is only for vaginal and penile use. The addition of anal use for the subject device does not represent a new intended use, which is the same for both the subject and predicate devices (e.g., to provide lubrication during intimate sexual activity).

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 lubricants are biocompatible.

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Shelf-Life:

The subject devices in this submission have the following shelf-life durations:

Grosz Warming Liquid - 15 months
Grosz Play Tingling 2 years ●
Grosz KY Yours — 2 years
Grosz KY Mine - 2 years

The shelf-life durations for the subject devices are based on the results of accelerated aging and real-time testing for Grosz Warming Liquid and Grosz KY Yours and accelerated aging testing for Grosz Play Tingling and Grosz KY Mine. All specifications for Grosz Warming Liquid/Grosz KY Yours and Grosz Play Tingling/Grosz KY Mine listed in Tables 1 and 2, respectively, were met throughout the shelf-life duration.

Condom Compatibility:

The compatibility of the subject devices was evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Grosz Warming Liquid was determined to be compatible with natural rubber latex, polyisoprene and polyurethane condoms. Grosz Play Tingling was determined to be compatible with natural rubber latex and polyisoprene condoms, and not compatible with polyurethane condoms. Grosz KY Yours & Mine when used together as intended, was determined to be compatible with natural rubber latex and polyisoprene condoms, and not compatible with polyurethane condoms.

Conclusion:

The results of the performance testing described above demonstrate that Grosz Warming Liquid, Grosz Play Tingling, and Grosz KY Yours & Mine are as safe and effective as their respective predicate devices and support a determination of substantial equivalence.

Regulation Number and Section

§ 884.5300 Condom.

(a)
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.(b)
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.