Cleared Traditional

K801069 - STERILE ISOLATION GOWN

K801069 is the FDA 510(k) clearance for STERILE ISOLATION GOWN by Medspec Corp.. It is a Class 2 General Hospital device (product code FYC) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K801069 · Medspec Corp. · General Hospital
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May 1980
Decision
14d
Days
Class 2
Risk

K801069 is an FDA 510(k) clearance for the STERILE ISOLATION GOWN. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Medspec Corp. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1980 after a review of 14 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 Medspec Corp. devices

Submission Details

510(k) Number K801069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1980
Decision Date May 20, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
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.