Cleared Traditional

K120045 - EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV

K120045 is an FDA 510(k) clearance for EMM HIGH PERFORMANCE SURGICAL GOWN WITH..., manufactured by Exact Medical Manufacturing, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K120045 · Exact Medical Manufacturing, Inc. · General Hospital
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Jun 2012
Decision
158d
Days
Class 2
Risk

K120045 is an FDA 510(k) clearance for the EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Exact Medical Manufacturing, Inc. (Buffalo, US). The FDA issued a Cleared decision on June 12, 2012 after a review of 158 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 Exact Medical Manufacturing, Inc. devices

FDA 510(k) Submission Details - K120045

510(k) Number K120045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2012
Decision Date June 12, 2012
Days to Decision 158 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
29d slower than avg
Panel avg: 129d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 175
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