Cleared Traditional

K971920 - GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) (FDA 510(k) Clearance)

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

K971920 · Customed, Inc. · General Hospital
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Dec 1997
Decision
195d
Days
Class 2
Risk

K971920 is an FDA 510(k) clearance for the GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on December 4, 1997 after a review of 195 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 Customed, Inc. devices

Submission Details

510(k) Number K971920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1997
Decision Date December 04, 1997
Days to Decision 195 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 128d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 292
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