Cleared Abbreviated

Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)

K232849 · Owens & Minor (O&M) Halyard, Inc. · General Hospital
May 2024
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K232849 is an FDA 510(k) clearance for the Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311), a Gown, Isolation, Surgical (Class II — Special Controls, product code FYC), submitted by Owens & Minor (O&M) Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on May 16, 2024, 245 days after receiving the submission on September 14, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K232849 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2023
Decision Date May 16, 2024
Days to Decision 245 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FYC — Gown, Isolation, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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