Cleared Traditional

KENTRON'S ISOLATION GOWN (K971917) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K971917 · Kentron Health Care, Inc. · General Hospital
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Sep 1997
Decision
119d
Days
Class 2
Risk

K971917 is an FDA 510(k) clearance for the KENTRON'S 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 119 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 Kentron Health Care, Inc. devices

Submission Details

510(k) Number K971917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1997
Decision Date September 19, 1997
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 67
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