Cleared Traditional

K972410 - IMPERVIOUS ISOLATION GOWN

K972410 is an FDA 510(k) clearance for IMPERVIOUS ISOLATION GOWN, manufactured by Kentron Health Care, Inc.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K972410 · Kentron Health Care, Inc. · General Hospital
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Sep 1997
Decision
85d
Days
Class 2
Risk

K972410 is an FDA 510(k) clearance for the IMPERVIOUS ISOLATION GOWN. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Kentron Health Care, Inc. (Springfield, US). The FDA issued a Cleared decision on September 19, 1997 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.

View all Kentron Health Care, Inc. devices

FDA 510(k) Submission Details - K972410

510(k) Number K972410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1997
Decision Date September 19, 1997
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

Product Code FYC Gown, Isolation, 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 - FYC Gown, Isolation, Surgical

All 48
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K972410.
100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN
K003749 · Banta Healthcare · Feb 2001
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · Allegiance Healthcare Corp. · Aug 1998
KENTRON'S ISOLATION GOWN
K971917 · Kentron Health Care, Inc. · Sep 1997
FAR-EAST BARRIER GOWNS
K971702 · Far East Science & Technology Development Co., Ltd. · Jul 1997
NON-STERILE ISOLATION GOWN
K970814 · American Seal Co. · May 1997
ISOLATION GOWN
K960999 · Copioumed Intl., Inc. · Dec 1996