Cleared Traditional

Medline Orbis LVL 3 Surgical Gown

K220333 · Medline Industries, LP · General Hospital
May 2022
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K220333 is an FDA 510(k) clearance for the Medline Orbis LVL 3 Surgical Gown, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Medline Industries, LP (Nortfield, US). The FDA issued a Cleared decision on May 18, 2022, 103 days after receiving the submission on February 4, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K220333 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2022
Decision Date May 18, 2022
Days to Decision 103 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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