(169 days)
Bucked Stride Silicone Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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.
#LubeLife Thin Silicone Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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.
JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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.
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant are clear, thin, liquid personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
The Bucked Stride Silicone Lubricant product is to be sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in clear polyethylene terephthalate (PET) cylinder bottles are capped with matte black pumps covered with a metallic coated polypropylene (PP) overcap and shrink wrapped to ensure product integrity.
#LubeLife Thin Silicone Lubricant is to be sold as an over-the-counter (OTC) product in 8 fl. oz./240 mL size bottles. This product is provided in clear, polyethylene terephthalate (PET) cylinder bottles and capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is to be sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in clear, polyethylene terephthalate (PET) cylinder bottles. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
The provided text is a 510(k) Summary for personal lubricants and does not contain information about a medical device that utilizes artificial intelligence or requires extensive clinical studies with human readers or image interpretation. Therefore, a direct answer to the prompt's request for acceptance criteria and studies proving the device meets them, especially those pertaining to AI model performance (like MRMC studies, ground truth establishment for training/test sets, expert adjudication, etc.), cannot be extracted from this document.
The document focuses on the physical and chemical properties, biocompatibility, shelf-life, and condom compatibility of the personal lubricants. The "acceptance criteria" discussed are essentially the device specifications and the results of non-clinical performance testing.
However, I can provide the available information in a structured way that addresses the spirit of the request as much as possible, mapping the given content to the closest relevant sections of your prompt.
Acceptance Criteria and Study for Personal Lubricants (K190858)
1. Table of Acceptance Criteria and the Reported Device Performance:
The device's performance is demonstrated through non-clinical testing against established specifications.
| Property / Acceptance Criteria | Reported Device Performance |
|---|---|
| Appearance | Clear, thin liquid |
| Color | Clear, colorless |
| Odor | Odorless |
| Viscosity (cps) | 200 to 325 cps |
| Specific Gravity | 0.850 to 1.025 |
| Antimicrobial effectiveness per USP <51> | Meets US <51> acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP <61> and <1111> | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) per USP <61> and <1111> | Less than 10 cfu/g |
| Presence of Pathogens per USP <62>: | |
| - Pseudomonas aeruginosa | Absent |
| - Staphylococcus aureus | Absent |
| - Salmonella/Shigella | Absent |
| - Escherichia coli | Absent |
| - Candida albicans | Absent |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing, non-systemically toxic. |
| Shelf-Life | 2 years (met specifications at all time points) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of distinct "samples" in microbiological or physical testing terms, but testing was performed on "various packaging types" and "largest volumes associated with each packaging type" for shelf-life, considered "worst case." Biocompatibility tests would involve animal models or cell cultures, but specific numbers are not provided.
- Data Provenance: The studies were non-clinical performance testing (laboratory-based). The country of origin for the data is not specified, but the submission is to the U.S. FDA. The studies are by nature prospective as they are designed to test the product's compliance with specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is not applicable as the device is a personal lubricant, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" here is the adherence to physicochemical and biological specifications, determined by standard laboratory methods and validated against USP and ISO standards.
4. Adjudication Method for the Test Set:
- Not applicable. Performance is assessed against predetermined quantitative and qualitative specifications using laboratory measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where AI assists human readers (e.g., radiologists) in interpreting medical images. The device in this submission is a personal lubricant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this concept is not applicable. The device is a physical product, not an algorithm. Its "standalone performance" refers to its intrinsic properties and safety/effectiveness without human applied intervention beyond its intended use.
7. The Type of Ground Truth Used:
- For this device, the "ground truth" is based on:
- Validated laboratory methods and specifications: Adherence to physical properties (viscosity, specific gravity, appearance, color, odor).
- Industry and regulatory standards: Compliance with USP (<51>, <61>, <62>, <1111>) for antimicrobial effectiveness and microbial counts.
- International standards (ISO 10993-series) and FDA guidance: For biocompatibility testing (cytotoxicity, sensitization, irritation, acute systemic toxicity).
- ASTM standards (ASTM D7661-10): For condom compatibility.
8. The Sample Size for the Training Set:
- Not applicable. This device is a manufactured product, not an AI model that undergoes "training."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As the "training set" concept does not apply to this product, neither does the establishment of its ground truth.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
September 18, 2019
United Consortium Marlent Perez Quality Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355
Re: K190858
Trade/Device Name: Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 15, 2019 Received: August 19, 2019
Dear Marlent Perez:
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.
{1}------------------------------------------------
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 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-regulatory-information/postmarketing-safety-reportingcombination-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 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 Sharon Andrews 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 Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K190858
Device Name
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant
Indications for Use (Describe)
Bucked Stride Silicone Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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.
#LubeLife Thin Silicone Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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.
JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is a silicone-based personal lubricant for pende, anal and/or vaginal application. intended to lubricate and moisturize, 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 ) |
|---|
| ---------------------------------------------------------- |
| 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 regardingthis 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."
{3}------------------------------------------------
510 (k) Summary - K190858
1. Submitter Information
| Applicant: | United Consortium |
|---|---|
| Contact: | Marlent PerezQuality SpecialistBruce AlbertHead of Technical Services |
| Address: | 29000 N. Hancock ParkwayValencia, CA 91355 |
| Phone: | (661) 295-1700, ext. 1007 |
| FAX: | (661) 295-1800 |
2. Correspondent Information
| Contact: | Marlent Perez |
|---|---|
| Address: | 29000 N. Hancock ParkwayValencia, CA 91355 |
| Phone: | (661) 295-1700, ext. 1007 |
| Fax: | (661) 295-1800 |
| Email: | mperez@systemjo.com |
3. Date prepared: September 16, 2019
4. Device Information
Device Name:
| Lubricant and JO XTRA SILKY Ultra-Thin Silicone PersonalLubricant | |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone
5. Predicate Device Information
| Device Name: | Silicone Personal Lubricant, ALL-IN-ONE |
|---|---|
| 510(k) Number: | K180083 |
| Manufacturer: | United Consortium |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |
The predicate device has not been subject to a design-related recall.
6. Device Description
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant are clear, thin, liquid personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
{4}------------------------------------------------
The Bucked Stride Silicone Lubricant product is to be sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in clear polyethylene terephthalate (PET) cylinder bottles are capped with matte black pumps covered with a metallic coated polypropylene (PP) overcap and shrink wrapped to ensure product integrity.
#LubeLife Thin Silicone Lubricant is to be sold as an over-the-counter (OTC) product in 8 fl. oz./240 mL size bottles. This product is provided in clear, polyethylene terephthalate (PET) cylinder bottles and capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is to be sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in clear, polyethylene terephthalate (PET) cylinder bottles. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
The device specifications are listed in the table below :
Table 1: Device Specifications for Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant
| Property | Specification |
|---|---|
| Appearance | Clear, thin liquid |
| Color | Clear, colorless |
| Odor | Odorless |
| Viscosity (cps) | 200 to 325 cps |
| Specific Gravity | 0.850 to 1.025 |
| Antimicrobial effectiveness per USP <51> | Meets US <51> acceptance criteria forCategory 2 products |
| Total aerobic microbial count (TAMC) perUSP <61> and <1111> | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) perUSP <61> and <1111> | Less than 10 cfu/g |
| Presence of Pathogens per USP <62> | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |
7. Indications for Use
Bucked Stride Silicone Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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.
#LubeLife Thin Silicone Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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.
{5}------------------------------------------------
JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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.
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below lists the a comparison of the indications for use and technological characteristics of the subject and predicate device.
| Bucked Stride SiliconeLubricant #LubeLife ThinSilicone LubricantJO XTRA SILKY Ultra-Thin Silicone PersonalLubricant | Silicone PersonalLubricant, ALL-IN-ONE(K180083) | |
|---|---|---|
| Device ClassificationName | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | Bucked Stride Silicone Lubricantis a silicone-based personallubricant for penile, anal and/orvaginal application, intended tolubricate and moisturize, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex and polyisoprene condoms.This product is not compatiblewith polyurethane condoms.#LubeLife Thin SiliconeLubricant is a silicone-basedpersonal lubricant for penile, analand/or vaginal application,intended to lubricate andmoisturize, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms. | Silicone Personal Lubricant is asilicone- based personallubricant for penile, anal and/orvaginal application, intended tolubricate and moisturize, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex, polyurethane andpolyisoprene condoms.ALL-IN-ONE is a silicone-based personal lubricant forpenile, anal and/or vaginalapplication, intended to lubricateand moisturize, to enhance theease and comfort of intimatesexual activity and supplementthe body's natural lubrication.This product is compatible withnatural rubber latex,polyurethane andpolyisoprene condoms. |
Table 2: Comparator Table for Subject Device - Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant and Predicate Device Silicone Personal Lubricant, ALL-IN-ONE
{6}------------------------------------------------
| Feature | Bucked Stride SiliconeLubricant #Lube Life ThinSilicone LubricantJO XTRA SILKY Ultra-Thin Silicone PersonalLubricant | Silicone PersonalLubricant, ALL-IN-ONE(K180083) |
|---|---|---|
| Water soluble | No | No |
| Contains water | No | No |
| Primary ingredients | Dimethicone, Dimethiconol,Tocopheryl (Vitamin E) Acetate | Dimethicone, Dimethiconol |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Natural Rubber Latex,Polyisoprene | Natural Rubber Latex,Polyisoprene, Polyurethane |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 2 years | 2 years |
The subject and predicate device have similar indications for use and have the same intended use. The subject and predicate device have similar technological characteristics, including similar formulation and shelf-life. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.
9. Summary of Non-Clinical Performance Testing
Biocompatibility
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing were performed in accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- . Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010) ●
- Vaginal Irritation (ISO 10993-10:2010)
{7}------------------------------------------------
- Penile Irritation (ISO 10993-10:2010) ●
- Acute Systemic Toxicity (ISO 10993-11:2006) ●
The results of this testing demonstrated that the subject lubricant isnon-cytotoxic, non-irritating, and nonsensitizing, and non-systemically toxic ..
Shelf-Life
The subject device is a non-sterile personal lubricant with a two-year shelf-life in accordance with the results of real time and accelerated aging studies on the various packaging types available for the lubricants, i.e., bottles with cap and bottles with pump closure. All device specifications listed in Table 1 were evaluated for the largest volumes associated with each packaging type which were considered worst case for evaluating shelf-life. The subject device specifications at all time points.
Condom Compatibility
The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated that Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant are compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms.
10. Conclusion
The results of the performance testing described above demonstrate that the Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant are as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.