Cleared Traditional

K811958 - BOUNDARY REINFORCED OR GOWN

K811958 is the FDA 510(k) clearance for BOUNDARY REINFORCED OR GOWN by The Buckeye Cellulose Corp.. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K811958 · The Buckeye Cellulose Corp. · General Hospital
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Jul 1981
Decision
18d
Days
Class 2
Risk

K811958 is an FDA 510(k) clearance for the BOUNDARY REINFORCED OR GOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by The Buckeye Cellulose Corp. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1981 after a review of 18 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 The Buckeye Cellulose Corp. devices

Submission Details

510(k) Number K811958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1981
Decision Date July 27, 1981
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
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 148
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K811958.
BARRIER SURGICAL GOWN
K852870 · Surgikos, Inc. · Jul 1985
BOUNDARY SINGLE-USE OR GOWN
K842958 · Procter & Gamble Mfg. Co. · Aug 1984
BOUNDARY SINGLE-USE GOWNS
K834332 · Procter & Gamble Mfg. Co. · May 1984
WHITE KNIGHT DISP. STERILE BACK GOWN
K800927 · G.D. Searle and Co. · May 1980
WHITE KNIGHT SURGICAL PACK
K800929 · G.D. Searle and Co. · May 1980
STERILIZATION PROCESS /USE GOWNS
K792622 · Procter & Gamble Mfg. Co. · Jan 1980