Cleared Special

K142166 - TOTAL SHIELD SURGICAL

Also marketed or referenced as:
TOGA(REGULAR, LARGE,X-LARGE) HOOD HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES

K142166 is an FDA 510(k) clearance for TOTAL SHIELD SURGICAL, manufactured by Zimmer, Inc.. 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.

K142166 · Zimmer, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
29d
Days
Class 2
Risk

K142166 is an FDA 510(k) clearance for the TOTAL SHIELD SURGICAL. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Zimmer, Inc. (Dover, US). The FDA issued a Cleared decision on August 28, 2014 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 - K142166

510(k) Number K142166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2014
Decision Date August 28, 2014
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 266
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K142166.
SmartGownTM surgical gown
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SURGICAL GOWN
K141467 · Xuchang Zhengde Environstar Medical Products Co.,L · Mar 2015
SURGICAL GOWN
K141606 · Cobes Industries Co., Ltd. · Nov 2014
STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
K141095 · Stryker Corporation · Aug 2014
AERO BLUE PERFORMANCE SURGICAL GOWN
K140539 · Kimberly Clark Corporation · Jun 2014
T4/T5 HYTREL TOGAS
K121664 · Stryker Corporation · Mar 2014
K142166 · TOTAL SHIELD SURGICAL
Download PDF FDA Summary Zimmer, Inc.