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Condom

by Polar Latex, Ltd.

510(k) K960710

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 NumberK960710 Date10 Oct 1996ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
HIS
FDA applicant
Polar Latex , Ltd.
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The device is a Class II condom manufactured by Polar Latex, Ltd. It is designed for use in obstetrics and gynecology applications and may also be used to collect semen to aid in the diagnosis of infertility.

The device is available in various sizes and is regulated under product code HIS. It received FDA 510(k) clearance on October 10, 1996, after a 232-day review process. The device is classified under special controls for both natural rubber latex condoms and those made of materials other than natural rubber latex, including natural membrane or synthetic materials.

Questions

AI-generated answers, 26 Sep 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 primary purpose of this condom device?

    This condom is designed for use in obstetrics and gynecology applications and may also be used to collect semen to aid in the diagnosis of infertility. It is manufactured by Polar Latex, Ltd. and is available in various sizes.

  • What regulatory status does this condom have?

    The device received FDA 510(k) clearance on October 10, 1996, after a 232-day review process. It is classified as a Class II medical device under product code HIS and is regulated under special controls for both natural rubber latex condoms and those made of other materials.

  • What materials are these condoms made of?

    The condoms are available in various materials including natural rubber latex as well as materials other than natural rubber latex, such as natural membrane or synthetic materials. The specific material options are not detailed in the provided information.

  • How is this device supplied and stored?

    The device is supplied in various sizes as indicated in the description. However, specific details about packaging, sterility, single-use or reuse status, and storage conditions are not provided in the device data.