Cleared Traditional

K220333 - Medline Orbis LVL 3 Surgical Gown

K220333 is an FDA 510(k) clearance for Medline Orbis LVL 3 Surgical Gown, manufactured by Medline Industries, LP. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 103-day FDA review.

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

K220333 is an FDA 510(k) clearance for the Medline Orbis LVL 3 Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on May 18, 2022 after a review of 103 days - within the typical 510(k) review window.

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, LP devices

FDA 510(k) Submission Details - K220333

510(k) Number K220333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 129d · This submission: 103d
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 212
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K220333.
35g Standard SMMS Surgical Gown
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Surgical Gown, Blue, Sterile
K220665 · Excellent Medical Technology Group Co., Ltd. · Jun 2022
Plus Medical Cover Gown
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K214108 · Medline Industries, LP · May 2022
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K211036 · Foshan Nanhai Plus Medical Co, Ltd. · May 2022