Cleared Special

K022162 - STRYKER T4 URETHANE HOOD

Also marketed or referenced as:
STRYKER T4 URETHANE ZIPPER TOGA STRYKER T4 URETHANE PULLOVER TOGA

K022162 is an FDA 510(k) clearance for STRYKER T4 URETHANE HOOD, manufactured by Stryker Instruments. The device is a Class 2 General Hospital device with product code FYA cleared through the Special 510(k) pathway after a 29-day FDA review.

K022162 · Stryker Instruments · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
29d
Days
Class 2
Risk

K022162 is an FDA 510(k) clearance for the STRYKER T4 URETHANE HOOD. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K022162

510(k) Number K022162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2002
Decision Date August 01, 2002
Days to Decision 29 days
Submission Type Special
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
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 296
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K022162.
SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN
K023635 · Sri/Surgical Express, Inc. · Nov 2002
PRIMAGARD SURGICAL GOWNS
K023266 · Primeline Medical Products, Inc. · Nov 2002
BREATHABLE SURGICAL GOWN
K023167 · Allegiance Healthcare Corp. · Oct 2002
ULTRAGARD IMPERVIOUS REINFORCED GOWN
K013846 · Precept Medical Products, Inc. · May 2002
CONVERTORS SMS POLYOLEFIN GOWN
K020593 · Allegiance Healthcare Corp. · Mar 2002
MASTER & FRANK SURGICAL GOWNS (STERILE)
K012186 · Master & Frank Ent. Co., Ltd. · Dec 2001
K022162 · STRYKER T4 URETHANE HOOD
Download PDF FDA Summary Stryker Instruments