Cleared Traditional

K260310 - HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL)

Also marketed or referenced as:
HALYARD* Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL)
K260310 · O&M Halyard, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
271d
Days
-
Risk

K260310 is an FDA 510(k) clearance for the HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL).

Submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on October 28, 2026 after a review of 271 days - an extended review cycle.

This device falls under the General Hospital FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K260310

510(k) Number K260310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2026
Decision Date October 28, 2026
Days to Decision 271 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 129d · This submission: 271d
Pathway characteristics
Predicate-based equivalence.

QSO Device Classification - Class ,

Product Code QSO
Device Class -
K260310 · HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL)
Download PDF FDA Summary O&M Halyard, Inc.