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Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve

by Cardinal Health 200, LLC

510(k) K193327

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK193327 Date20 Mar 2020ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0897-2026 FDA Class II initiated 12 Nov 2025

    Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

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  • Withdrawn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
FYA
FDA applicant
Cardinal Health200, LLC
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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