Skip to content

Kleen Test O.R. Kit

by Kleen Test Products

510(k) K890098

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 NumberK890098 Date24 Jan 1989ClearedStatusActive

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  • Withdrawn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
LRO
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Kleen Test O.R. Kit is a surgical kit intended for use in general and plastic surgery procedures. It is classified under product code LRO and was determined to be substantially equivalent to a predicate device. The kit is designed to support operative environments by providing necessary components for surgical preparation and cleanup.

This device is supplied by Kleen Test Products, a contract manufacturer based in Elkhorn, Wisconsin. It is intended for single use in surgical settings and is regulated under FDA 510(k) clearance with k-number K890098. The kit is packaged for sterile use and should be stored in a dry, controlled environment. Its use is limited to the operating room and is not intended for reuse or reprocessing.

Other devices from Kleen Test Products Corporation

See all devices from Kleen Test Products Corporation →

Questions

AI-generated answers, 22 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 types of surgeries is the Kleen Test O.R. Kit designed for?

    The kit is intended for general and plastic surgery procedures. It provides the components needed for operative preparation and cleanup, matching the needs of those specialties as indicated in its advisory committee description.

  • Is the Kleen Test O.R. Kit supplied sterile and for single‑use only?

    Yes, the kit is packaged for sterile use and is designated for single‑use in the operating room. The device description explicitly states it is not intended for reuse or reprocessing, ensuring infection control standards are met.

  • How should the Kleen Test O.R. Kit be stored before use?

    The kit should be stored in a dry, controlled environment. Maintaining dryness and temperature control preserves sterility and prevents degradation of the kit components until the point of use.

  • What regulatory clearance does the Kleen Test O.R. Kit have?

    The kit received FDA 510(k) clearance, identified by k-number K890098, and was determined to be substantially equivalent to a predicate device. This traditional clearance confirms it meets the necessary safety and performance criteria.

  • Who manufactures and supplies the Kleen Test O.R. Kit?

    The kit is supplied by Kleen Test Products, a contract manufacturer located in Elkhorn, Wisconsin, USA. Their contact information is listed as GARY L SWANSON, with the address P.O. Box 140, Elkhorn, WI 53121.