One Touch Condom with Benzocaine
by Thai Nippon Rubber Industry Public Company Limited
510(k) K171213
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK171213 | Date12 Jan 2018 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 26 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- HIS
- FDA applicant
- Thai Nippon Rubber Industry Public Company Limited.
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5300
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a condom (FDA Product Code: HIS), a barrier contraceptive designed to prevent pregnancy and sexually transmitted infections by covering the penis during sexual intercourse. The latex condom incorporates benzocaine, a local anesthetic, to reduce discomfort during application or use.
The One Touch Condom with Benzocaine is supplied as a single-use, non-sterile product intended for home or clinical use. It is classified as a Class II medical device under FDA regulations (21 CFR § 884.5300) and has received FDA 510(k) clearance (K171213) as substantially equivalent to predicate devices. Storage conditions are not specified in the regulatory data.
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Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the benzocaine in this condom, and how does it differ from standard condoms?
The benzocaine in the One Touch Condom with Benzocaine serves as a local anesthetic to reduce discomfort during application or use. Unlike standard condoms, which are designed solely as barrier contraceptives to prevent pregnancy and sexually transmitted infections, this version includes benzocaine to minimize irritation or sensitivity that some users may experience when putting on or using a condom.
Is this condom intended for reuse, or is it meant to be used only once?
The One Touch Condom with Benzocaine is explicitly labeled as a single-use product, meaning it should not be reused after one application. This aligns with standard condom safety guidelines to prevent potential damage or contamination.
What storage conditions should be followed for this product, and why aren’t they specified in the regulatory data?
The regulatory data does not specify storage conditions for the One Touch Condom with Benzocaine. Typically, latex condoms should be stored in a cool, dry place away from direct sunlight and extreme temperatures to maintain integrity. Since no explicit storage instructions are provided in the submission, users should follow general latex product guidelines unless manufacturer-specific instructions are available.
How is this device regulated, and what does the FDA’s 510(k) clearance mean for its use?
The One Touch Condom with Benzocaine is classified as a Class II medical device under FDA regulations (21 CFR § 884.5300) and has received FDA 510(k) clearance (K171213). This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meaning it meets the same performance standards and safety requirements. Clinicians and users can rely on this clearance as evidence of regulatory review for its intended use as a barrier contraceptive.