Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
The Lubricant, Personal, Gamete, Fertilization, and Embryo Compatible is an obstetrics/gynecology device for penile and/or vaginal application intended to moisturize and lubricate while being compatible with gametes, fertilization processes, and embryos, making it suitable for use by couples undergoing fertility treatments. It falls under the Obstetrics/Gynecology medical specialty and is classified as a Class 2 device under regulation 884.5300, requiring 510(k) premarket notification. Standard personal lubricants can be harmful to sperm and embryos, making this specialized compatibility an important regulatory distinction. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PEB
- Device Class
- FDA class 2
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. This device is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. This device may also be used during fertility interventions to facilitate entry of diagnostic and therapeutic devices.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K212885 | Actively Trying Personal Lubricant Rose Scented | Feb 11, 2022 | Substantially Equivalent | CC Wellness, LLC |
| K212705 | Actively Trying Personal Lubricant Unfragrance | Feb 09, 2022 | Substantially Equivalent | CC Wellness, LLC |
| K193450 | Pre-Seed Fertility Lubricant | Jul 23, 2020 | Substantially Equivalent | Church & Dwight Co., Inc. |
| K190872 | BioGenesis Fertility Lubricant | Nov 07, 2019 | Substantially Equivalent | Good Clean Love, Inc. |
| K182585 | JO Actively Trying Personal Lubricant | Apr 26, 2019 | Substantially Equivalent | United Consortium |
| K162319 | BabyDance Fertility Lubricant | Apr 28, 2017 | Substantially Equivalent | Fairhaven Health, LLC |
| K141132 | ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT | Jan 09, 2015 | Substantially Equivalent | Biofilm, Inc. |
| K131355 | CONCEIVE PLUS | Nov 07, 2013 | Substantially Equivalent | Sasmar, Inc. |
| K072741 | PRE-VA VAGINAL LUBRICANT | Jul 16, 2008 | Substantially Equivalent | Ingfertility, LLC |
| K051436 | PRE' VAGINAL LUBRICANT | Oct 13, 2006 | Substantially Equivalent | Ingfertlity, LLC |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.