Cleared Traditional

K801162 - BARRIER PLUS SURGEON GOWNS

K801162 is an FDA 510(k) clearance for BARRIER PLUS SURGEON GOWNS, manufactured by American Hospital Supply Corp.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K801162 · American Hospital Supply Corp. · General Hospital
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May 1980
Decision
8d
Days
Class 2
Risk

K801162 is an FDA 510(k) clearance for the BARRIER PLUS SURGEON GOWNS. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by American Hospital Supply Corp. (Walker, US). The FDA issued a Cleared decision on May 23, 1980 after a review of 8 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 American Hospital Supply Corp. devices

FDA 510(k) Submission Details - K801162

510(k) Number K801162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1980
Decision Date May 23, 1980
Days to Decision 8 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
121d faster than avg
Panel avg: 129d · This submission: 8d
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 43
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K801162.
MAXIMUM CONTROL GOWN
K874318 · Ulti-Med Intl., Inc. · Dec 1987
DISPOSABLE ISOLATION GOWN
K851823 · American Threshold Industries, Inc. · May 1985
CONTROL COVER GOWN
K840229 · Kimberly-Clark Corp. · Mar 1984
ISOLATION GOWN
K780605 · Abco Dealers, Inc. · May 1978
ISOLATION GOWN PACK
K761080 · American Hospital Supply Corp. · Jan 1977
CLEANING AND ISOLATION ROOM KIT
K760904 · American Hospital Supply Corp. · Dec 1976