Cleared Traditional

K160471 - Medline Non-Surgical Isolation Gown-

K160471 is an FDA 510(k) clearance for Medline Non-Surgical Isolation Gown-, manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K160471 · Medline Industries, Inc. · General Hospital
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Jan 2017
Decision
347d
Days
Class 2
Risk

K160471 is an FDA 510(k) clearance for the Medline Non-Surgical Isolation Gown-. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on January 31, 2017 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K160471

510(k) Number K160471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2016
Decision Date January 31, 2017
Days to Decision 347 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
218d slower than avg
Panel avg: 129d · This submission: 347d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

Product Code FYC Gown, Isolation, 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 - FYC Gown, Isolation, Surgical

All 39
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K160471.
Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
K202310 · Wildcat Ppe, LLC · Jan 2021
AMD Ritmed AssureWear VersaGown
K190306 · Amd Medicom, Inc. · Jan 2020
SURGICAL ISOLATION GOWN
K171535 · Jingzhou Haixin Green Cross Medical Products Co., Ltd. · Feb 2018
Cardinal Health Isolation Gown
K160339 · Cardinal Health200, LLC · Jul 2016
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · Allegiance Healthcare Corp. · Aug 1998
KOOL GARD SINGLES GOWN
K952114 · American Threshold Industries, Inc. · Sep 1995