Cleared Traditional

K101468 - 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE

K101468 is an FDA 510(k) clearance for 3M BASIC DISPOSABLE SURGICAL GOWN, manufactured by 3M Company Corp. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K101468 · 3M Company Corp · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
322d
Days
Class 2
Risk

K101468 is an FDA 510(k) clearance for the 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFOR.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by 3M Company Corp (St. Paul, US). The FDA issued a Cleared decision on April 14, 2011 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K101468

510(k) Number K101468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2010
Decision Date April 14, 2011
Days to Decision 322 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
193d slower than avg
Panel avg: 129d · This submission: 322d
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 270
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K101468.
EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
K111535 · Exact Medical Manufacturing, Inc. · Aug 2011
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
SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO
K102692 · Hangzhou Jincheng Medical Supplier Manufacture Co. · Mar 2011
FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
K102971 · Microtek Medical, Inc. · Feb 2011
BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN
K093835 · Bam Corp., Ltd. · Feb 2011
K101468 · 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE
Download PDF FDA Summary 3M Company Corp