Cleared Traditional

POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS (K925077) - FDA 510(k) Clearance

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

K925077 · Medtek Development Corp. · General Hospital
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Aug 1993
Decision
313d
Days
Class 2
Risk

K925077 is an FDA 510(k) clearance for the POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Medtek Development Corp. (Bloomington, US). The FDA issued a Cleared decision on August 16, 1993 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medtek Development Corp. devices

Submission Details

510(k) Number K925077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1992
Decision Date August 16, 1993
Days to Decision 313 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
184d slower than avg
Panel avg: 129d · This submission: 313d
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.