Cleared Traditional

BOUNDARY REINFORCED SINGLE-USE GOWNS (K834339) - FDA 510(k) Clearance

K834339 · Procter & Gamble Mfg. Co. · General & Plastic Surgery device
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Mar 1984
Decision
84d
Days
-
Risk

K834339 is an FDA 510(k) clearance for the BOUNDARY REINFORCED SINGLE-USE GOWNS.

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984 after a review of 84 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 Procter & Gamble Mfg. Co. devices

Submission Details

510(k) Number K834339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1983
Decision Date March 05, 1984
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -