pjur® WOMAN Aloe 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 condoms. This product is not compatible with polyurethane and polyisoprene condoms.

pjur® med Moisturising glide is a personal lubricant for penile, vaginal 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 condoms. This product is not compatible with polyurethane and polyisoprene condoms.

pjur® BACK DOOR water-based 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 condoms. This product is not compatible with polyurethane and polyisoprene condoms.

pjur® analyse me! water-based 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 condoms. This product is not compatible with polyurethane and polyisoprene condoms.

pjur® med NATURAL glide 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.

We-Vibe® Lube made by pjur® 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 polvisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

The pjur® WOMAN Aloe, pjur® analyse me! water-based, pjur® BACK DOOR water-based, pjur® med Moisturising glide, pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are water-based personal lubricants provided non-sterile. These over-the-counter products have similar formulations and contain neither a contraceptive nor a spermicide. The pjur® analyse me! waterbased, pjur® BACK DOOR water-based, and pjur® med Moisturising glide are compatible with natural rubber latex condoms. They are not compatible with polyurethane and polyisoprene condoms. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.

The pjur® WOMAN Aloe has a formulation that consists of water, glycerin, xanthan gum, benzyl alcohol, sodium benzoate, citric acid, potassium sorbate, aloe barbadensis leaf juice powder. This lubricant is provided in 30 ml, 100 ml, and 250 ml polyethylene bottles. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® have the same formulation that includes the same components as the lubricant above, without aloe barbadensis leaf juice powder. The pjur® med NATURAL glide device is provided in 10 ml and 100 ml polyethylene bottles. We-Vibe® Lube made by pjur® is provided in 30 ml polyethylene bottles, and 125 ml polyethylene/polypropylene pump bottles. The pjur® analyse me! water-based, pjur® BACK DOOR water-based, and pjur® med Moisturising glide have the same formulation that consists of water, glycerin, xanthan gum, benzyl alcohol, sodium benzoate, potassium sorbate, citric acid, sodium hyaluronate. The pjur® analyse me! water-based is provided in 10 ml, 100ml, and 250 ml polyethylene bottles. pjur® BACK DOOR water-based is provided in 10 ml, 100 ml, and 250 ml polyethylene bottles. pjur® med Moisturising qlide is provided in 10 ml and 100 ml polyethylene bottles.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a series of personal lubricants. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel safety or effectiveness through clinical trials, especially for common, low-risk devices like personal lubricants.

Therefore, the document does not describe a study with ground truth established by experts, multi-reader multi-case studies, or AI algorithm performance. Instead, it details non-clinical testing/performance data to demonstrate that the new devices meet established safety and performance criteria, primarily through comparison to a predicate device and adherence to recognized standards.

Here's an attempt to answer your questions based on the provided document, highlighting where the information is not applicable to an AI/medical imaging context:

Acceptance Criteria and Device Performance (based on Table 1: Device Specifications)

Parameter	Acceptance Criteria (Specification) & Method Used	Reported Device Performance (Implied by "can maintain their specifications")
Appearance	Visual: Opaque fluid	Met
Odor	Olfactory: Characteristic (pjur® WOMAN Aloe) / Odorless (others)	Met
pH	USP<791>: 4.0-4.5	Met
Viscosity (mPa*s)	USP<912>: 8500-9500 (pjur® WOMAN Aloe) / 9000-12000 (pjur® med Moisturising glide, BACK DOOR, analyse me!) / 8000-9500 (pjur® med NATURAL glide, We-Vibe® Lube)	Met
Osmolality (mOsmol/kg)	USP<785>: 400-550 (1:9.5/9.8 dilution) / 400-600 (1:9.5 dilution)	Met
Total Aerobic Microbial Count (TAMC)	USP<61>: <100 CFU/g	Met
Total Yeast and Mold Count (TYMC)	USP<61>: <10 CFU/g	Met
Presence of pathogenic organisms	USP<62>: Absent (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans)	Met
Antimicrobial Preservation	USP<51>: Category 2 - Topical (specific log reduction/no increase criteria)	Met

Study Details:

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" as would be in an AI study. The "test set" here refers to samples of the manufactured lubricant products. For microbiological tests (TAMC, TYMC, pathogenic organisms, antimicrobial preservation), chemical tests (pH, viscosity, osmolality), and physical tests (appearance, odor), samples from production batches would be tested. The specific number of samples tested for each parameter is not detailed.
- Data Provenance: The data comes from in-vitro laboratory testing of the manufactured lubricant products. The country of origin of the data is not specified, but the applicant's address is in Luxembourg. The testing is prospective in the sense that it's performed on samples of the actual products being brought to market to verify they meet specifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this submission. This is not a study establishing "ground truth" for medical diagnosis via expert consensus. Instead, the "ground truth" for these performance criteria is defined by established scientific/technical standards and laboratory measurements (e.g., pH meter readings, culture results). The expertise lies in the certified laboratory personnel performing these tests according to the USP and ASTM standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for interpreting medical images, to resolve discrepancies between expert readers. For the physical, chemical, and microbiological tests described here, the results are quantitative or qualitative assessments based on standardized procedures, not subjective interpretations requiring reader adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools and involves human readers interpreting cases. This submission is for personal lubricants, not diagnostic software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an AI algorithm. This question is not applicable to the device described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these tests is based on established measurement standards and chemical/microbiological properties of the product, as defined by recognized pharmacopeial monographs (USP) and ASTM standards. For example, a pH meter provides the "ground truth" for pH, and specific culture methods provide the "ground truth" for microbial presence/count. Condom compatibility is verified through mechanical testing as per ASTM D7661. Biocompatibility relies on adherence to ISO 10993 standards.
The sample size for the training set:
- Not applicable. This is not an AI model, so there is no training set in the machine learning sense. The "training" for such products involves formulation development and process optimization to consistently meet the specified product characteristics.
How the ground truth for the training set was established:
- Not applicable. As there is no AI training set, this question does not apply.

Summary

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February 19, 2021

pjur group Luxembourg SA % Candace Cederman Consultant Candace F. Cederman 722 Arjean Drive Wilmington, NC 28411

Re: K200527

Trade/Device Name: pjur® WOMAN Aloe, pjur® med Moisturising glide, pjur® BACK DOOR water-based, pjur® analyse me! water-based, pjur® med NATURAL glide, We-Vibe® Lube made by pjur® Regulation Number: 21 CFR§ 884.5300

Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 20, 2021 Received: January 21, 2021

Dear Candace Cederman:

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.

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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 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing 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 (OS) 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 medical devices and radiation-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,

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) K200527

Device Name

pjur® WOMAN Aloe, pjur® med Moisturising glide, pjur® BACK DOOR water-based, pjur® med NATURAL glide, We-Vibe® Lube made by pjur®

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/1 description: The image shows the logo for Pjur Group. The logo consists of the word "pjur" in a stylized font, with a yellow circle above the "j". Below "pjur" is the word "group" in a smaller, gray font. Below the logo is the text "510(k) Summary K200527".

DATE PREPARED:	19 February 2021
APPLICANT:	pjur group Luxembourg SA87 esplanade de la MoselleL-6637 Wasserbillig, LuxembourgTelephone: +352 74-8989Fax: +352 74-8990
CONTACT:	Andrea Giebel, Quality Management Representative
TRADE NAME:	• pjur® WOMAN Aloe• pjur® analyse me! water-based• pjur® BACK DOOR water-based• pjur® med Moisturising glide• pjur® med NATURAL glide• We-Vibe® Lube made by pjur®
COMMON NAME:	Personal Lubricant
REGULATION NUMBER:	21 CFR 884.5300
REGULATION NAME	Condom
PRODUCT CODE	NUC (Lubricant, Personal)
DEVICE CLASS:	II
PREDICATE DEVICE:	KY Banksy Moisture, K183505The predicate device has not been subject to a design-related recall.

DEVICE DESCRIPTION:

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Table 1: Device Specifications
--------------------------------	--

Parameter	Method	Specification• pjur® WOMAN Aloe	Specification• pjur® med Moisturisingglide• pjur® BACK DOORwater-based• pjur® analyse me! water-based	Specification• pjur® med NATURALglide• We-Vibe® Lube made bypjur®
Appearance	Visual	Opaque fluid	Opaque fluid	Opaque fluid
Odor	Olfactory	Characteristic	Odorless	Odorless
pH	USP<791>	4.0-4.5	4.0-4.5	4.0-4.5
Viscosity(mPa*s)	USP<912>	8500-9500	9000-12000	8000-9500
Osmolality(mOsmol/kg)	USP<785>	400 - 550 (1:9.5 dilution)	400 - 550 (1:9.8 dilution)	400 - 600 (1:9.5 dilution)
Total AerobicMicrobialCount(TAMC)	USP<61>	<100 CFU/g	<100 CFU/g	<100 CFU/g
Total Yeastand MoldCount(TYMC)	USP<61>	<10 CFU/g	<10 CFU/g	<10 CFU/g
Presence ofpathogenicorganisms	USP<62>	PseudomonasaeruginosaStaphylococcusaureusCandidaalbicans	AbsentPseudomonasaeruginosaStaphylococcusaureusCandidaalbicans	AbsentPseudomonasaeruginosaStaphylococcusaureusCandidaalbicans
AntimicrobialPreservation	USP<51>	Category 2 - Topical,bacteria should show notless than 2.0 log reductionat 14 days and noincrease from 14-daycount at the 28-day count.Yeast and molds shouldshow no increase from theinitial calculated count at14 and 28 days.	Category 2 - Topical,bacteria should show notless than 2.0 log reductionat 14 days and noincrease from 14-daycount at the 28-day count.Yeast and molds shouldshow no increase from theinitial calculated count at14 and 28 days.	Category 2 - Topical,bacteria should show notless than 2.0 log reductionat 14 days and noincrease from 14-daycount at the 28-day count.Yeast and molds shouldshow no increase from theinitial calculated count at14 and 28 days.

INDICATIONS FOR USE:

pjur® med Moisturising glide 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 condoms. This product is not compatible with polyurethane and polyisoprene condoms.

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We-Vibe® Lube made by pjur® 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.

COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES:

	pjur® WOMANAloeK200527Subject Device	pjur® medMoisturising glidepjur® BACK DOORwater-basedpjur® analyse me!water-basedK200527Subject Device	pjur® medNATURAL glideWe-Vibe® LubeK200527Subject Device	KY BanksyMoistureK183505Predicate Device	Comparison
Indications forUse	pjur® WOMAN Aloeis a personallubricant for penile,vaginal and/or analapplication,intended tomoisturize andlubricate, enhancethe ease andcomfort of intimatesexual activity andsupplement thebody's naturallubrication. Thisproduct iscompatible withnatural rubber latexcondoms. Thisproduct is notcompatible withpolyurethane andpolyisoprenecondoms.	[Product name] is apersonal lubricantfor penile, vaginaland/or analapplication,intended tomoisturize andlubricate, enhancethe ease andcomfort of intimatesexual activity andsupplement thebody's naturallubrication. Thisproduct iscompatible withnatural rubber latexcondoms. Thisproduct is notcompatible withpolyurethane andpolyisoprenecondoms.	[Product name] is apersonal lubricantfor penile, vaginaland/or analapplication,intended tomoisturize andlubricate, enhancethe ease andcomfort of intimatesexual activity andsupplement thebody's naturallubrication. Thisproduct iscompatible withnatural rubber latexand polyisoprenecondoms. Thisproduct is notcompatible withpolyurethanecondoms.	This product isintended for penile,vaginal and/or analapplication,intended tomoisturize andlubricate, enhancethe ease andcomfort of intimatesexual activity andsupplement thebody's naturallubrication. Thisproduct iscompatible withnatural rubber latexand polyisoprenecondoms. Thisproduct is notcompatible withpolyurethanecondoms.	Sameintended use
Rx / OTC	OTC	OTC	OTC	OTC	Same
Base Type	Water	Water	Water	Water	Same
PrimaryIngredients	Water, Glycerin,Xanthan Gum,Benzyl Alcohol,Sodium Benzoate,Citric Acid,Potassium Sorbate,Aloe Barbadensis	Water, Glycerin,Xanthan Gum,Benzyl Alcohol,Sodium Benzoate,Potassium Sorbate,Citric Acid, SodiumHyaluronate	Water, Glycerin,Xanthan Gum,Benzyl Alcohol,Sodium Benzoate,Potassium Sorbate,Citric Acid	Xanthan Gum,Propanediol,Glycerin, BenzoicAcid, Purac BFP/41, Sodiumhyaluronate, Water	Different

Table 2: Comparison of Intended Use and technological characteristics of the subject and predicate devices:

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	Leaf Juice Powder(Aloe Vera)
Appearance	Opaque Liquid	Opaque Liquid	Opaque Liquid	Clear	Different
Odor	Characteristic	Odorless	Odorless	Odorless	Similar
Viscosity	8500 - 9500 mPas	9000 - 12000 mPas	8000 - 9500 mPas	3000 - 8000 cps	Different
pH	4.0-4.5	4.0-4.5	4.0-4.5	3.5-4.5	Similar
Osmolality	400-550 mOsm/kg	400-550 mOsm/kg	400-600 mOsm/kg	850-1200 mOsm/kg	Different
	(1:9.5 dilution)	(1:9.8 dilution)	(1:9.5 dilution)
Microbial Limits	TAMC: <100 cfu/g	TAMC: <100 cfu/g	TAMC: <100 cfu/g	TAMC: <100 cfu/g	Same
	TYMC: <10 cfu/g	TYMC: <10 cfu/g	TYMC: <10 cfu/g	TYMC: <10 cfu/g
	Pathogenic	Pathogenic	Pathogenic	Pathogenic
	Organisms: Absent	Organisms: Absent	Organisms: Absent	Organisms: Absent
AntimicrobialEffectiveness	Yes	Yes	Yes	Yes	Same
Testing
(USP<51>
Category 2)
Sterile	No	No	No	No	Same
Biocompatibility	Yes	Yes	Yes	Yes	Same
Tested
Condom	Compatible with	Compatible with	Compatible with	Compatible with	Similar
Compatibility	natural rubber latex	natural rubber latex	natural rubber latex	natural rubber latex
	condoms. Not	condoms. Not	and polyisoprene	and polyisoprene
	compatible with	compatible with	condoms. Not	condoms. Not
	polyurethane and	polyurethane and	compatible with	compatible with
	polyisoprene	polyisoprene	polyurethane	polyurethane
	condoms	condoms	condoms	condoms
Packaging	Polyethylene bottles	Polyethylene bottles	Polyethylene bottlesPolyethylene/PolypropylenePump bottles	Polyethylene bottles	Similar




Shelf Life	4 years (bottles)	4 years (bottles)	4 years (bottles)	2 years	Different

The indications for use for the subject and predicate devices are not identical as there are differences in condom compatibility for some of the predicate devices (i.e., not compatible with polyisoprene condoms). These differences do not represent a new intended use as both the subject and predicate devices are intended to provide lubrication during intimate sexual activity.

The subject and predicate devices have different technological characteristics, including different formulations, specifications, shefi-life, packaging, etc. as identified in the differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

NON-CLINICAL TESTING/PERFORMANCE DATA:

CONDOM COMPATIBILITY:

Condom compatibility testing was performed in accordance with ASTM D7661 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Testing demonstrated that the pjur® WOMAN Aloe, pjur® analyse me! water-based, pjur® BACK DOOR waterbased, and pjur® med Moisturising glide are compatible with natural rubber latex condoms. They are not compatible with polyurethane and polyisoprene condoms. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.

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BIOCOMPATIBILITY:

Biocompatibility studies were performed in accordance with the 2020 FDA quidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing" as follows:

. Cytotoxicity: ISO 10993-5:2009
Sensitization: ISO 10993-10:2010 ●
Systemic Toxicity: ISO 10993-11:2017
Vaginal Irritation: ISO 10993-10:2010 .

The results of the testing show that the formulations of the subject devices are biocompatible.

SHELF-LIFE:

pjur® WOMAN Aloe, pjur® med Moisturising glide, pjur® BACK DOOR water-based, pjur® analyse me! water-based, pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® have a shelf-life of 4 years when packaged in polyethylene bottles and a shelf-life of 3 years when packaged in polyethylene/ polypropylene pump bottles, in accordance with the results of real-time aged stability studies. Results from testing demonstrated that the devices can maintain their specifications as shown in Table 1 over the stated shelf-life duration.

CONCLUSION:

The results of the performance testing demonstrate that the pjur® med Moisturising glide, pjur® BACK DOOR water-based, pjur® analyse me! water-based, pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® personal lubricants are as safe and effective as the predicate device and support a substantial equivalence determination.

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.