Cleared Traditional

K970814 - NON-STERILE ISOLATION GOWN

K970814 is an FDA 510(k) clearance for NON-STERILE ISOLATION GOWN, manufactured by American Seal Co.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K970814 · American Seal Co. · General Hospital
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May 1997
Decision
82d
Days
Class 2
Risk

K970814 is an FDA 510(k) clearance for the NON-STERILE ISOLATION GOWN. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by American Seal Co. (Hayward, US). The FDA issued a Cleared decision on May 27, 1997 after a review of 82 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 Seal Co. devices

FDA 510(k) Submission Details - K970814

510(k) Number K970814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1997
Decision Date May 27, 1997
Days to Decision 82 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 129d · This submission: 82d
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 K970814.
KENTRON'S ISOLATION GOWN
K971917 · Kentron Health Care, Inc. · Sep 1997
IMPERVIOUS ISOLATION GOWN
K972410 · Kentron Health Care, Inc. · Sep 1997
FAR-EAST BARRIER GOWNS
K971702 · Far East Science & Technology Development Co., Ltd. · Jul 1997
KOOL GARD SINGLES GOWN
K952114 · American Threshold Industries, Inc. · Sep 1995
BARRIER GOWN, KOOL-GARD BACKLESS GOWN
K952115 · American Threshold Industries, Inc. · Sep 1995
COVER GOWN
K952116 · American Threshold Industries, Inc. · Sep 1995