Contempo or Private Label Flavored Condom

• • Terminated Z-0717-2013 FDA Class II ·initiated 5 Nov 2012

  One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.

• • Terminated Z-0402-03 FDA Unclassified (pre-2012) ·initiated 25 Nov 2002 ·on shared 510(k) K000408

  The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Full name

Lifestyles, Contempo or Private Label Strawberry, Vanilla, or Banana Flavored Condom

510(k) Number

K000408 ↗

FDA Product Code

HIS

FDA applicant

Suretex Prophylactics , Ltd.

Device Class

Class II

Regulation

21 CFR Part 884.5300

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors

  Class II

  FDA 510(k) K983320 Active Cleared 11 Dec 1998

• Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors

  Class II

  FDA 510(k) K981621 Active Cleared 19 Jun 1998

• Various Ansell Tradenames or Private Label

  Class II

  FDA 510(k) K992081 Active Cleared 19 Aug 1999

• Are these flavored condoms sterile, and if not, what does that mean for their use?

  No, these flavored condoms (strawberry, vanilla, or banana) are non-sterile, meaning they are not free from bacteria, fungi, or other microorganisms. This is typical for condoms, as sterility is not required for this type of device. However, the product still meets performance and safety standards like ASTM D3492-16 and ISO 4074:2015 to ensure reliability for contraception and protection against sexually transmitted infections. Non-sterility does not affect their primary function—barrier protection—but users should follow general hygiene practices before and after use.

• How are these condoms supplied, and do they come in multiple sizes or models?

  These condoms are supplied as single-use units in flavored varieties (strawberry, vanilla, or banana) but the provided data does not specify individual sizes or models beyond the product line (Lifestyles, Contempo, or private label). The FDA product code HIS categorizes them as general-purpose condoms, which typically include standard sizes (e.g., medium, large). For exact sizing details, refer to the manufacturer’s packaging or product literature, as variations may exist between brands or private-label versions.

• What storage conditions should be followed for these flavored condoms to maintain their integrity?

  While the data does not explicitly outline storage instructions, standard recommendations for condoms—including flavored varieties—are to keep them in a cool, dry place away from direct sunlight or heat sources. Avoid storing them in glove compartments, wallets, or areas prone to extreme temperatures, as this can degrade the material and compromise effectiveness. Always check the packaging for any manufacturer-specific storage guidance.

• What does the FDA’s classification as Class II and the 510(k) clearance (K000408) mean for clinicians or buyers?

  The FDA’s Class II classification indicates these condoms are subject to special controls (e.g., performance standards like ASTM D3492-16) to ensure safety and effectiveness without requiring pre-market approval. The 510(k) clearance (K000408) confirms the manufacturer demonstrated the device is substantially equivalent to a legally marketed predicate, meaning it meets the same intended use (contraception/STI protection) and performance criteria. This does not imply clinical approval for specific patient populations but assures regulatory compliance for general use.