Cleared Traditional

K882281 - GOWN, ISOLATION, SURGICAL (FYC)

K882281 is an FDA 510(k) clearance for GOWN, manufactured by A Plus International, Inc.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K882281 · A Plus International, Inc. · General Hospital
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Jun 1988
Decision
23d
Days
Class 2
Risk

K882281 is an FDA 510(k) clearance for the GOWN, ISOLATION, SURGICAL (FYC). Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by A Plus International, Inc. (La Puente, US). The FDA issued a Cleared decision on June 23, 1988 after a review of 23 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 A Plus International, Inc. devices

FDA 510(k) Submission Details - K882281

510(k) Number K882281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1988
Decision Date June 23, 1988
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

Product Code FYC Gown, Isolation, 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 - FYC Gown, Isolation, Surgical

All 49
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K882281.
COVER GOWN
K952116 · American Threshold Industries, Inc. · Sep 1995
BUSE STAFF PROTECTION GOWNS AND KITS
K941845 · Busse Hospital Disposables, Inc. · May 1995
OREX ISOLATION GOWN
K945223 · Thantex Specialties, Inc. · Apr 1995
ISOLATION GOWN
K874888 · Sage Products, Inc. · Dec 1987
MAXIMUM CONTROL GOWN
K874318 · Ulti-Med Intl., Inc. · Dec 1987
DISPOSABLE ISOLATION GOWN
K851823 · American Threshold Industries, Inc. · May 1985