Cleared Traditional

K202447 - Medline Orbis Surgical Gown

K202447 is the FDA 510(k) clearance for Medline Orbis Surgical Gown by Medline Industries, Inc.. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K202447 · Medline Industries, Inc. · General Hospital
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Apr 2021
Decision
219d
Days
Class 2
Risk

K202447 is an FDA 510(k) clearance for the Medline Orbis Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on April 2, 2021 after a review of 219 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. 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.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K202447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2020
Decision Date April 02, 2021
Days to Decision 219 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 129d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FYA Gown, Surgical

All 147
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K202447.
AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown
K210688 · O&M Halyard, Inc. · Jul 2021
Surgical Gowns
K210215 · Jiangsu Province Jianerkang Medical Dressing Co., Ltd. · Jul 2021
Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown
K211422 · Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · Jul 2021
Medical Surgical Gowns
K202844 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · Jan 2021
Surgical Gown (Sterile), Surgical Gown (Non-sterile)
K202706 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · Dec 2020
Modular Toga
K200977 · Operating Room Innovations, Inc. · Aug 2020