← Product Code [LTZ](/productcode/LTZ) · K931220

# SPERMICIDAL LUBRICATED CONDOM (K931220)

_Monsys USA, Inc. · LTZ · May 22, 1996 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K931220

## Device Facts

- **Applicant:** Monsys USA, Inc.
- **Product Code:** [LTZ](/productcode/LTZ.md)
- **Decision Date:** May 22, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5310
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Indications for Use

Condoms, when properly used, are an effective way to prevent pregnancy, although no contraceptive can guarantee 100 % effectiveness. They will also reduce the risk of spreading sexually transmitted diseases such as AIDS, syphilis, etc.

## Device Story

Spermicidal lubricated condom; manufactured from natural latex type FA; intended for use by individuals to prevent pregnancy and reduce transmission of sexually transmitted diseases; physical barrier function; requires visual inspection for package or product damage prior to use; storage in cool, dry place required.

## Clinical Evidence

Bench testing only; device meets or exceeds all ASTM and ISO standards for condoms per FDA requirements.

## Technological Characteristics

Natural latex type FA; spermicidal lubricant; meets ASTM and ISO standards; tested per ISO 2004.

## Regulatory Identification

A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).

## Submission Summary (Full Text)

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K931220

SAFETY AND EFFECTIVENESS SUMMARY

MAY 22 1995

Classification name : Condom (Rubber) Contraceptive

Classification Number : 85 HIS

Proprietary Name : The device in this 510(K) summary is a spermicidal lubricated condom. The condom will be sold under various trade names including Eros, Iris, Amoret, Galant, Gemini, Brillant, Casanova and Galla.

Intended Use and Performance Claim : Condoms, when properly used, are an effective way to prevent pregnancy, although no contraceptive can guarantee 100 % effectiveness. They will also reduce the risk of spreading sexually transmitted diseases such as AIDS, syphilis, etc.

Physical Composition : Condoms are manufactured from natural latex type FA. The latex is purchased from traditional territories of Malaysia and is of the highest quality which is tested according to ISO 2004.

Specifications : All specifications for these condoms meet or exceed all ASTM and ISO standards for condoms according to FDA requirements.

Safety Guidlines: When using a condom follow all instructions included with the condom. To assure that the condom will perform to its maximum quality level, follow this safety guideline:

**Do Not Use the Condom If:**

The external package has visual signs of being tampered with, or shows physical damage possibly due to mishandling. The individual foil wrapping of the condom is damaged. The condom itself has damage (a tear or rip, is cracked or dried up or has any deformities as compared to a regular Spermicidal lubricated condom). Any other apparent damage that would cause a suspicion of the loss of integrity to the condom. The condoms should be stored in the cool and dry place.

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**Source:** [https://fda.innolitics.com/device/K931220](https://fda.innolitics.com/device/K931220)

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