Cleared Traditional

K111535 - EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER

K111535 is an FDA 510(k) clearance for EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER, 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 85-day FDA review.

K111535 · Exact Medical Manufacturing, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
85d
Days
Class 2
Risk

K111535 is an FDA 510(k) clearance for the EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER. 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 August 26, 2011 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K111535

510(k) Number K111535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2011
Decision Date August 26, 2011
Days to Decision 85 days
Submission Type Traditional
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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 266
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K111535.
SURGICAL GOWN, SMS
K121152 · Jiangsu Guangda Medical Material, Co., Ltd. · Dec 2012
DISPOSABLE SURGICAL GOWNS
K120192 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · Oct 2012
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
K120045 · Exact Medical Manufacturing, Inc. · Jun 2012
JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE
K111067 · Kunshan Jiehong Nonwoven Product Co., Ltd. · Aug 2011
SURGICAL PROCEDURE PACKS
K110724 · Omnia Spa · Jun 2011
3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE
K101468 · 3M Company Corp · Apr 2011
K111535 · EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
Download PDF FDA Summary Exact Medical Manufac…