Cleared Traditional

K972227 - SHOE COVER

K972227 is an FDA 510(k) clearance for SHOE COVER, manufactured by American Seal Co.. The device is a Class 1 General & Plastic Surgery device with product code FYF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K972227 · American Seal Co. · General & Plastic Surgery device
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Sep 1997
Decision
88d
Days
Class 1
Risk

K972227 is an FDA 510(k) clearance for the SHOE COVER. Classified as Cap, Surgical (product code FYF), Class I - General Controls.

Submitted by American Seal Co. (Hayward, US). The FDA issued a Cleared decision on September 9, 1997 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4040 - the FDA general and plastic surgery 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.

FDA 510(k) Submission Details - K972227

510(k) Number K972227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1997
Decision Date September 09, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

FYF Device Classification - Class 1, General Controls

Product Code FYF Cap, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FYF Cap, Surgical

All 18
Devices cleared under the same product code (FYF) and FDA review panel - the closest regulatory comparables to K972227.
NIOMED SURGICAL CAPS
K955833 · Amerasia Corp. · Mar 1996
SURGICAL CAP
K954556 · Thai Disposable Products Co., Ltd. · Mar 1996
NIOMED SURGICAL HOOD
K954454 · Amerasia Corp. · Jan 1996
NIOMED BOUFFANT CAPS
K954455 · Amerasia Corp. · Jan 1996
BOUFFANT CAP
K953878 · American Threshold Industries, Inc. · Jan 1996
SURGEON'S CAP
K953879 · American Threshold Industries, Inc. · Jan 1996
K972227 · SHOE COVER
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