(246 days)
Not Found
No
The device description and performance studies focus on the chemical composition, biocompatibility, and condom compatibility of a personal lubricant, with no mention of AI or ML technologies.
No
The device is a personal lubricant intended to moisturize and lubricate; it is not for treating an illness or disease (i.e. therapeutic).
No
The device is a personal lubricant intended to moisturize and lubricate for sexual activity, not to diagnose a condition or disease.
No
The device description clearly states it is a physical product (a jelly) provided in tubes and bottles, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This describes a device used externally on the body for physical comfort and function, not for testing samples taken from the body to diagnose or monitor a medical condition.
- Device Description: The description details a water-based lubricant with specific ingredients and packaging. There is no mention of reagents, test strips, or any components typically associated with in vitro diagnostic tests.
- Lack of IVD Indicators: The document does not mention any of the keywords or concepts commonly associated with IVDs, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases
- Measurement of analytes
- Laboratory use
- Calibration or quality control for diagnostic testing
The information provided clearly describes a Class II medical device intended for personal use as a lubricant, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Personal Lubricant Jelly is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane condoms and polyisoprene condoms.
Product codes
NUC
Device Description
Personal Lubricant Jelly is a clear, slightly yellow, water-based personal lubricant that is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms. The subject lubricant contains water, hydroxyethylcellulose, glycerin, phenoxyethanol, sodium benzoate, and lactic acid. The subject lubricant is provided in two types of packages: a 2 oz. and 4 oz. polyethylene tube with a screw on top, with sealing film placed over the tube, and a 2.5 oz high density polyethylene bottle with a screw on top. The subject lubricant is a personal lubricant for over the counter (OTC) use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal application
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: The biocompatibility of the subject lubricant was evaluated 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." The following tests were conducted:
- Cytotoxicity (ISO 10993-5:2010 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity)
- Sensitization (ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization)
- Vaginal Irritation (ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization)
- Acute Systemic Toxicity (ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity)
Result: The results of these tests demonstrated that the subject lubricant is non-sensitizing, non-irritating, and non-systematically toxic.
Condom compatibility: Condom Compatibility testing was conducted in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
Result: Test results demonstrated that the subject device is compatible with natural rubber latex condoms, but not compatible with polyurethane condoms and polyisoprene condoms.
Shelf life: Personal Lubricant Jelly has a shelf life of 3 years based on the results of an accelerated aging stability study per ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The device specifications listed in Table 1 were evaluated in the shelf-life study.
Result: The subject device met the device specifications across the shelf life duration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
May 18, 2021
Nantong Health & Beyond Hygienic Products, Inc. Michael Zhu General Manager No. 118, Yuxian road, North Town Street Rugao, Jiangsu 226575 China
Re: K202667 Trade/Device Name: Personal Lubricant Jelly Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 5, 2021 Received: April 23, 2021
Dear Michael Zhu:
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.
1
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/cdrl-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,
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
2
Indications for Use
510(k) Number (if known) K202667
Device Name Personal Lubricant Jelly
Indications for Use (Describe)
Personal Lubricant Jelly is a personal lubricant, for 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 condoms. This product is not compatible with polyurethane condoms and polyisoprene condoms.
| 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)
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3
510(K) Summary – K202667
Prepared Date: May 13, 2021
1. Submitter's Information
| Name: | NANTONG HEALTH & BEYOND HYGIENIC PRODUCTS INC. |
|---|---|
| Address: | No.118, Yuxian road, North Town Street Rugao City Jiangsu, |
| CHINA 226575 | |
| Contact person: | Michael Zhu |
| Title: | General manager |
| E-mail: | rd@healthandbeyond.cn |
| Tel: | 086-512-57108262 |
2. Device Identification
| Trade/Device Name: | Personal Lubricant Jelly | |
|---|---|---|
| Common name: | Personal Lubricant | |
| Regulation Number: | 21 CFR 884.5300 | |
| Regulation Name: | Condom | |
| Product Code: | NUC (Lubricant, Personal) | |
| Regulatory Class: | II |
3. Predicate Device
| 510(K) number: | K180764 |
|---|---|
| Device Name: | Trojan™ Azul Personal Lubricant (H2O Sensitive Touch |
| Personal Lubricant) |
The predicate device has not been subject to a design-related recall.
4. Device Description
Personal Lubricant Jelly is a clear, slightly yellow, water-based personal lubricant that is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms. The subject lubricant contains water, hydroxyethylcellulose, glycerin, phenoxyethanol, sodium benzoate, and lactic acid. The subject lubricant is provided in two types of packages: a 2 oz. and 4 oz. polyethylene tube with a screw on top, with sealing film placed over the tube, and a 2.5 oz high density polyethylene bottle with a screw on top. The subject lubricant is a personal lubricant for over the counter (OTC) use.
Device specifications are listed in Table 1 below:
4
| Parameter | Specification |
|---|---|
| Appearance | Liquid or gel free from foreign and |
| contaminating substance, no foul odor | |
| Color | Slightly yellow |
| Odor | No foul odor |
| pH per USP | 4.0-5.5 |
| Viscosity per USP | 900-2000 cps |
| Osmolality per USP | 450-600 mOsm/L (1:10 dilution) |
| Antimicrobial Effectiveness per USP | Meets USP acceptance criteria for |
| Category 2 specification products | |
| Total Microbial Count per USP | TAMC |
| Pseudomonas aeruginosa, Escherichia coli, | |
| Salmonella sp., Clostridium sp., Candida | |
| albicans) | Absent |
Table 1. Device Specifications for Personal Lubricant Jelly (Subject Device)
5. Indications for use
Personal Lubricant Jelly is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane condoms and polyisoprene condoms.
6. Comparison of Intended Use and Technological Characteristics to the Predicate Device
A comparison of the intended use and technological characteristics of the subject and predicate devices is provided in Table 2 below:
| Characteristics | Subject device | Predicate device
K180764 | Comparison |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | NANTONG HEALTH &
BEYOND HYGIENIC
PRODUCTS INC. | Church & Dwight Co., Inc. | -- |
| Trade name and
model | Personal Lubricant Jelly | TrojanTM Azul Personal
Lubricant (H2O Sensitive
Touch Personal Lubricant) | -- |
| | | | |
| Intended Use | Personal Lubricant Jelly is
a personal lubricant, for
penile and/or vaginal
application, intended to
moisturize and lubricate,
to enhance the ease and
comfort of intimate sexual
activity and supplement
the body's natural
lubrication. This product is
compatible with natural
rubber latex condoms.
This product is not
compatible with
polyurethane condoms
and polyisoprene
condoms. | Trojan Azul personal
lubricant (H2O sensitive
touch personal lubricant) is
a personal lubricant for
penile and/or vaginal
application, intended to
lubricate and moisturize, to
enhance to 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. | Similar |
| Condom
Compatibility | Natural Rubber Latex
(NRL) | NRL and polyisoprene | Different |
| Base Type | Water | Water | Same |
| Primary
Ingredients | Water
Hydroxyethylcellulose
Glycerin
Phenoxyethanol
Sodium Benzoate
Lactic Acid | Deionized Water
Glycerin
Symocide pH
(Phenoxyethanol,
Hydroxyacetophenone,
Caprylyl Glycol, Water)
Hydroxyethyl-
Cellulose
Sodium Hyaluronate
Sodium Citrate
Sodium Chloride
Citric Acid
Sodium Hydroxide
Vitamin E TPGS
Veragel 200
Standardized (Aloe
Barbadensis Leaf
Extract) | Different |
| Appearance | Clear Gel | Clear Gel | Same |
| Color | Slightly yellow | Clear and colorless | Different |
| Odor | No foul odor | Characteristic odor | Different |
| pH | 4.0-5.5 (25°C) | 5.9-6.9 | Different |
| Viscosity | 900-2000 CPS
(LVT#2 12 RPM, 1 min,
250 mL @ 25°C) | 1500-7500 | Different |
| Osmolality | 400-650 mOsm/L (1:10
dilution) | 250-550 mOsm/L | Different |
| Antimicrobial
effectiveness | Meets USP
acceptance criteria for
Category 2 specification
products | Meets Requirement | Same |
| TAMC |