Cleared Traditional

K214108 - Medline Orbis Chemo Surgical Gown

K214108 is the FDA 510(k) clearance for Medline Orbis Chemo Surgical Gown by Medline Industries, LP. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K214108 · Medline Industries, LP · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
128d
Days
Class 2
Risk

K214108 is an FDA 510(k) clearance for the Medline Orbis Chemo 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 6, 2022 after a review of 128 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

Submission Details

510(k) Number K214108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2021
Decision Date May 06, 2022
Days to Decision 128 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 129d · This submission: 128d
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 K214108.
Surgical Gown, Blue, Sterile
K220665 · Excellent Medical Technology Group Co., Ltd. · Jun 2022
Medline Orbis LVL 3 Surgical Gown
K220333 · Medline Industries, LP · May 2022
Plus Medical Cover Gown
K213177 · Foshan Nanhai Plus Medical Co, Ltd. · May 2022
Plus Medical Chemotherapy Gown
K211036 · Foshan Nanhai Plus Medical Co, Ltd. · May 2022
Disposable Surgical Gown
K214088 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · Apr 2022
Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
K203237 · Dukal Corporation · Mar 2022