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Saxon Spermicidal Condom

by Circle Rubber Corp.

510(k) K883467

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK883467 Date26 Oct 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
The Saxon Spermicidal Condom
510(k) Number
FDA Product Code
HIS
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Saxon Spermicidal Condom is a barrier contraceptive device classified as a condom. It combines a latex sheath with a spermicidal coating to provide dual protection against pregnancy by physically blocking sperm and chemically inhibiting their motility. Designed for male use, it is intended to be worn during sexual intercourse to prevent fertilization.

This device is supplied as a single-use, non-sterile product and is regulated under FDA 510(k) clearance (K883467). It falls under the product code HIS and is intended for use in obstetrics/gynecology settings. The device is available in standard sizes and must be stored in a cool, dry place away from direct sunlight. No MRI safety information is specified, and it is not intended for reuse.

Other devices from Circle Rubber Corp.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Saxon Spermicidal Condom used for?

    The Saxon Spermicidal Condom is designed as a barrier contraceptive for male use during sexual intercourse. It works by physically blocking sperm with a latex sheath while a spermicidal coating chemically inhibits sperm motility, providing dual protection against pregnancy.

  • Is the Saxon Spermicidal Condom sterile?

    No, the Saxon Spermicidal Condom is supplied as a non-sterile product. It is intended for single-use only, so sterility is not required for its intended application.

  • How should the Saxon Spermicidal Condom be stored?

    The device must be stored in a cool, dry place away from direct sunlight to maintain its integrity and effectiveness. Proper storage conditions help preserve the latex and spermicidal coating.

  • Can the Saxon Spermicidal Condom be reused?

    No, the Saxon Spermicidal Condom is explicitly designed for single-use only. Reuse is not recommended as it may compromise the barrier’s effectiveness and increase the risk of failure or damage.

  • What sizes are available for the Saxon Spermicidal Condom?

    The Saxon Spermicidal Condom is available in standard sizes, though exact measurements are not specified in the provided data. For precise sizing, refer to the manufacturer’s packaging or documentation.