Cleared Traditional

K982058 - ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN

K982058 is an FDA 510(k) clearance for ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN, manufactured by Encompass Group, LLC. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K982058 · Encompass Group, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
217d
Days
Class 2
Risk

K982058 is an FDA 510(k) clearance for the ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Encompass Group, LLC (Mcdonough, US). The FDA issued a Cleared decision on January 14, 1999 after a review of 217 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 Encompass Group, LLC devices

FDA 510(k) Submission Details - K982058

510(k) Number K982058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1998
Decision Date January 14, 1999
Days to Decision 217 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
88d slower than avg
Panel avg: 129d · This submission: 217d
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 K982058.
CONVERTORS SURGICAL GOWNS
K991034 · Allegiance Healthcare Corp. · Apr 1999
BARRIER SURGICAL GOWNS
K990395 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · Apr 1999
STERILE BACK SURGICAL GOWN WITH HAND TOWEL
K984422 · Medical Sterilization, Inc. · Apr 1999
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
K982694 · Medline Industries, Inc. · Dec 1998
ROTECNO 2000 SURGICAL GOWN
K982059 · Encompass Group, LLC · Nov 1998
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
K982693 · Medline Industries, Inc. · Oct 1998