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General regulatory and product information only, not medical advice. Anyone trying to conceive should talk to a clinician about their own situation.
Short answer
A fertility-friendly lubricant is a personal lubricant that FDA has cleared under product code PEB, “Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible”, a Class II device. In FDA’s own definition the product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. “Cleared” means a 510(k) found it substantially equivalent to a predicate; it does not mean FDA approved it, and the category is a lubricant, not a fertility treatment.
Definition and scope
openFDA’s device classification record for product code PEB (index last updated 2026-10-19, checked 2026-10-30) defines the device as 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.” It adds that the device “may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms,” that it “is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive,” and that it “may also be used during fertility interventions to facilitate entry of diagnostic and therapeutic devices.”
The same record lists the device as Class II, reviewed by the Obstetrics/Gynecology panel, filed under regulation number 884.5300, and not exempt from good manufacturing practice requirements. Regulation 884.5300 in 21 CFR (Cornell LII, checked 2026-10-30) is titled “Condom”; the regulation text defines condoms, so the PEB lubricant category sits under that number in FDA’s classification database rather than being described by the regulation text itself. For the regulatory pathway behind this, see FDA 510(k) premarket notification and FDA device classification, 510(k) and PMA.
How a PEB lubricant is evaluated in practice
The evidence behind the “sperm-compatible” claim is public in each product’s 510(k) summary. Two FDA 510(k) summaries, checked on 2026-10-30, show the typical elements:
- A human sperm survival assay (HSSA) and a lubricant barrier assay, used to show the product does not inhibit sperm motility.
- Biocompatibility testing against ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and vaginal irritation) and ISO 10993-11 (acute systemic toxicity).
- Where a latex condom claim is made, condom compatibility testing; the Pre-Seed summary cites ASTM D7661-10, the standard test method for compatibility of personal lubricants with natural rubber latex condoms.
- Product specifications and stability data that the sponsor sets for itself, such as pH, osmolality, endotoxin limit and shelf life.
What two FDA 510(k) records show
The table compares two cleared products, using only what each FDA document states. The specification values are the sponsors’ own acceptance criteria for those products, not FDA limits for the category.
| Item | Pre-Seed Fertility Lubricant (K193450, letter dated 2020-07-23) | Actively Trying Personal Lubricant Rose Scented (K212885, letter dated 2022-02-11) |
|---|---|---|
| Product code and regulation | PEB | PEB; regulation name listed as Condom (884.5300) |
| Gamete compatibility claim | Compatible with sperm, oocytes and embryos; usable by couples trying to conceive | Same |
| Latex and polyisoprene condoms | Compatible | Compatible |
| Polyurethane condoms | Not compatible | Not compatible |
| Sperm motility test | HSSA and lubricant barrier assay | HSSA: acceptance of at least 80% of control motility at 24 hours after 30 minutes’ exposure to 10% lubricant |
| Osmolality (sponsor specification) | 260-370 mOsm/kg | 300-410 mOsm/kg |
| pH (sponsor specification) | 7.0-7.4 | 7.25-7.80 (USP <971>) |
| Endotoxin (sponsor specification) | Not listed in this comparison | Below 0.5 EU/mL by LAL gel-clot (USP <85>) |
| Shelf life | 22 months, from accelerated and real-time stability | 2 years |
Sources: FDA 510(k) K193450 and FDA 510(k) K212885, checked 2026-10-30. Two products with the same code differ in their specifications, so a single “ideal” pH or osmolality is not something these records establish.
Where it matters for labs, clinics and supply decisions
- Intended use is part of the definition. FDA’s PEB definition covers use by couples trying to conceive and use during fertility interventions to ease entry of diagnostic and therapeutic devices. A general-purpose personal lubricant outside PEB has no such sperm, oocyte and embryo compatibility entry in this category.
- Condom compatibility is claimed product by product. The category definition says a PEB device “may or may not” be compatible with latex, polyisoprene or polyurethane condoms, and the two records above state different statements per material. Read the cleared indications for the specific product.
- The identifier to look for is the 510(k) number. Each cleared product has a K-number and a public decision letter; the PEB code in openFDA lists ten clearances as of 2026-10-30. Supply and clinic staff can match a product’s label claim to its decision letter. See predicate devices and substantial equivalence for how clearance is reasoned.
Label-reading checklist built from the records
- Is a 510(k) number or product code PEB stated, and does the number appear in FDA’s database?
- Does the cleared indication say compatible with sperm, oocytes and embryos?
- Which condom materials does the cleared indication name as compatible or not compatible?
- Are the stated shelf life and specifications those in the decision-letter summary?
Common misunderstandings
- “FDA approved.” These products are cleared through the 510(k) pathway, which relies on substantial equivalence to a predicate. Approval refers to premarket approval (PMA). The distinction is covered in FDA clearance vs approval.
- “It improves the chance of conception.” The FDA definition says the product is compatible with gametes and can be used by couples trying to conceive. It does not claim the product treats infertility or improves conception, and the FDA records cited here make no such claim.
- “All fertility lubricants work with all condoms.” The cleared statements above say otherwise: both products are not compatible with polyurethane condoms.
- “The CFR describes fertility lubricants.” The regulation number is 884.5300, whose text defines condoms; the lubricant category is identified through the product code and FDA’s classification record.
Frequently asked questions
Is a fertility-friendly lubricant FDA approved?
No product in this category is described by FDA as approved in the FDA records cited on this page. They are Class II devices cleared by 510(k) under product code PEB, which means FDA found each substantially equivalent to a legally marketed predicate.
What does “sperm-compatible” mean on a label?
In the two 510(k) summaries cited here, it rests on a human sperm survival assay and a lubricant barrier assay. K212885 states an acceptance criterion of at least 80% of control motility at 24 hours after 30 minutes’ exposure to 10% lubricant.
Can it be used with condoms?
It depends on the product. FDA’s PEB definition says compatibility with latex, polyisoprene and polyurethane condoms varies. K193450 and K212885 both state compatibility with natural rubber latex and polyisoprene condoms and incompatibility with polyurethane condoms.
Is a fertility lubricant a fertility treatment?
No. FDA’s definition describes a personal lubricant that moisturizes and lubricates and is compatible with gametes and embryos. It is not defined as a treatment for infertility.
Sources
- openFDA device classification, product code PEB: api.fda.gov classification record (checked 2026-10-30).
- 21 CFR 884.5300, Condom (Cornell LII) (checked 2026-10-30).
- FDA 510(k) K193450, Pre-Seed Fertility Lubricant (checked 2026-10-30).
- FDA 510(k) K212885, Actively Trying Personal Lubricant Rose Scented (checked 2026-10-30).
- Background on devices: What is a medical device?
