Cleared Traditional

K822925 - BOUNDARY SINGLE-USE GOWNS

K822925 is an FDA 510(k) clearance for BOUNDARY SINGLE-USE GOWNS, manufactured by The Buckeye Cellulose Corp.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K822925

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
Combination Product No
PCCP Authorized No
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.

FYA Device Classification - Class 2, Special Controls

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 227
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K822925.
TURQUOISE
K851559 · Roseburg SA · Apr 1985
BOUNDARY SINGLE-USE OR GOWN
K842958 · Procter & Gamble Mfg. Co. · Aug 1984
BOUNDARY SINGLE-USE GOWNS
K834332 · Procter & Gamble Mfg. Co. · May 1984
BOUNDARY PROCESS CHANGE
K821564 · The Buckeye Cellulose Corp. · Jul 1982
BOUNDARY
K820116 · The Buckeye Cellulose Corp. · Feb 1982
BONDARY SINGLE-USE OR GOWN
K813390 · The Buckeye Cellulose Corp. · Jan 1982