Cleared Traditional

K984422 - STERILE BACK SURGICAL GOWN WITH HAND TOWEL

K984422 is an FDA 510(k) clearance for STERILE BACK SURGICAL GOWN WITH HAND TOWEL, manufactured by Medical Sterilization, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K984422 · Medical Sterilization, Inc. · General Hospital
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Apr 1999
Decision
113d
Days
Class 2
Risk

K984422 is an FDA 510(k) clearance for the STERILE BACK SURGICAL GOWN WITH HAND TOWEL. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Medical Sterilization, Inc. (Syosset, US). The FDA issued a Cleared decision on April 2, 1999 after a review of 113 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 Medical Sterilization, Inc. devices

FDA 510(k) Submission Details - K984422

510(k) Number K984422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1998
Decision Date April 02, 1999
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
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 212
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K984422.
CONVERTORS BREATHABLE SURGICAL GOWNS
K992514 · Allegiance Healthcare Corp. · Aug 1999
CONVERTORS SURGICAL GOWNS
K991034 · Allegiance Healthcare Corp. · Apr 1999
BARRIER SURGICAL GOWNS
K990395 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · Apr 1999
ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN
K982058 · Encompass Group, LLC · Jan 1999
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
K982694 · Medline Industries, Inc. · Dec 1998
ROTECNO 2000 SURGICAL GOWN
K982059 · Encompass Group, LLC · Nov 1998