Cleared Traditional

K822925 - BOUNDARY SINGLE-USE GOWNS

K822925 is the FDA 510(k) clearance for BOUNDARY SINGLE-USE GOWNS 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 103-day FDA review.

K822925 · The Buckeye Cellulose Corp. · General Hospital
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Jan 1983
Decision
103d
Days
Class 2
Risk

K822925 is an FDA 510(k) clearance for the BOUNDARY SINGLE-USE GOWNS. 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 January 12, 1983 after a review of 103 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 The Buckeye Cellulose Corp. devices

Submission Details

510(k) Number K822925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1982
Decision Date January 12, 1983
Days to Decision 103 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
26d faster than avg
Panel avg: 129d · This submission: 103d
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 K822925.
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