Cleared Traditional

K843721 - DISPOSABLE ISOLATION GOWN (FDA 510(k) Clearance)

K843721 · Anago, Inc. · General & Plastic Surgery device
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Oct 1984
Decision
31d
Days
-
Risk

K843721 is an FDA 510(k) clearance for the DISPOSABLE ISOLATION GOWN.

Submitted by Anago, Inc. (Fort Worth, US). The FDA issued a Cleared decision on October 25, 1984 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Anago, Inc. devices

Submission Details

510(k) Number K843721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1984
Decision Date October 25, 1984
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 114d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -