Cleared Traditional

K160361 - PRIMAGARD Isolation Gown (AAMI PB70 Lev...

K160361 is an FDA 510(k) clearance for PRIMAGARD Isolation Gown (AAMI PB70 Lev..., manufactured by Primed Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K160361 · Primed Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
269d
Days
Class 2
Risk

K160361 is an FDA 510(k) clearance for the PRIMAGARD Isolation Gown (AAMI PB70 Level 3). Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Primed Medical Products, Inc. (Edmonton, CA). The FDA issued a Cleared decision on November 4, 2016 after a review of 269 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 Primed Medical Products, Inc. devices

FDA 510(k) Submission Details - K160361

510(k) Number K160361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2016
Decision Date November 04, 2016
Days to Decision 269 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 129d · This submission: 269d
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 34
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K160361.
AMD Ritmed AssureWear VersaGown
K190306 · Amd Medicom, Inc. · Jan 2020
SURGICAL ISOLATION GOWN
K171535 · Jingzhou Haixin Green Cross Medical Products Co., Ltd. · Feb 2018
Medline Non-Surgical Isolation Gown-
K160471 · Medline Industries, Inc. · Jan 2017
Cardinal Health Isolation Gown
K160339 · Cardinal Health200, LLC · Jul 2016
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · Allegiance Healthcare Corp. · Aug 1998
BUSE STAFF PROTECTION GOWNS AND KITS
K941845 · Busse Hospital Disposables, Inc. · May 1995