Cleared Traditional

K132386 - TOTALSHIELD SURGICAL HELMET SYSTEM (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132386 · Zimmer, Inc. · General Hospital
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Dec 2013
Decision
144d
Days
Class 2
Risk

K132386 is an FDA 510(k) clearance for the TOTALSHIELD SURGICAL HELMET SYSTEM. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Zimmer, Inc. (Indianpolis, US). The FDA issued a Cleared decision on December 23, 2013 after a review of 144 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 Zimmer, Inc. devices

Submission Details

510(k) Number K132386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2013
Decision Date December 23, 2013
Days to Decision 144 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
15d slower than avg
Panel avg: 129d · This submission: 144d
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 293
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K132386.
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
K260725 · Hindernis DE Mexico, S.A.P.I. DE C.V. · May 2026
Cardinal Health™ Poly Reinforced Surgical Gown
K253243 · Cardinal Health 200, LLC · Apr 2026
Non-sterile Level 3 Surgical Gown (4025)
K253003 · Hubei Xinxin Non-Woven Co., Ltd. · Apr 2026
Copioumed AAMI 3 Surgical Gown
K251860 · Copioumed International, Inc. · Feb 2026
Henan Yadu Level 4 Surgical Gowns (Reinforced)
K252301 · Yadu Medical (Henan) Co., Ltd. · Feb 2026
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
K250564 · Yadu Medical (Henan) Co., Ltd. · Dec 2025