Cleared Traditional

K202447 - Medline Orbis Surgical Gown

K202447 is an FDA 510(k) clearance for Medline Orbis Surgical Gown, manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K202447

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.

FYA Device Classification - Class 2, Special Controls

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 211
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