What SKYN Original is
SKYN Original is a lubricated male condom made from synthetic polyisoprene. FDA cleared it through the 510(k) process on July 25, 2016 (K160399), as a Class II condom under 21 CFR 884.5300, product code MOL (synthetic condom) (FDA 510(k) K160399; FDA product classification MOL).
Its 510(k) summary gives the indication as contraception and prophylaxis, "to help reduce the risk of pregnancy and the transmission of sexually transmitted infections". It describes a condom about 180 mm long and 53 ± 2 mm wide, coated with a silicone gel lubricant containing a fragrance oil to mask the odor of the material, with a five-year shelf life. The clearance rests on bench, shelf-life and biocompatibility testing (including sensitization and irritation tests) of its one change from an earlier polyisoprene condom, the added fragrance oil, not on a clinical trial (K160399 510(k) summary).
What the evidence shows for polyisoprene
- Condoms protect. Consistent condom use cut HIV incidence by about 80% in a Cochrane review, an estimate for male condoms in general PMID: 11869658, and prospective studies link condom use to protection against chlamydia, gonorrhea, HSV-2 and syphilis PMID: 15356939.
- Non-latex condoms break more often. In a Cochrane review of randomized trials, non-latex condoms made of polyurethane or other synthetic materials had higher clinical breakage than latex, though the reviewers still called them an acceptable alternative for people who cannot use latex PMID: 16437459. The abstract does not list a polyisoprene condom among those tested.
- CDC's view. CDC says polyurethane condoms give protection comparable to latex, but that the effectiveness of other synthetic condoms in preventing STIs "has not been extensively studied" (CDC STI treatment guidelines: primary prevention).
That is why SKYN Original gets an evidence grade of B here, one step below latex.
Who SKYN Original suits
Choose SKYN Original if you or a partner have a latex allergy or sensitivity, or you prefer non-latex material. The maker states that SKYN condoms do not contain natural rubber latex and are suitable for people with a known or suspected latex allergy (SKYN Original product page, viewed October 3, 2026), and latex allergy is a reaction to natural rubber latex protein PMID: 15327474. Pair it with a water- or silicone-based lubricant: polyisoprene is just as sensitive to oil as latex (WHO/UNFPA/FHI 360 advisory note).
Consider Trojan Original if latex is not a problem for either partner, since latex is the most common material and the comparison standard in trials of non-latex condoms, and some non-latex designs broke more often than latex in those trials PMID: 16437459. Our guide to latex-free condoms covers materials, latex allergy, lubricants and internal condoms in more detail.