Cleared Traditional

K904276 - DISPOSABLE BEARD COVER

K904276 is an FDA 510(k) clearance for DISPOSABLE BEARD COVER, manufactured by Anago, Inc.. The device is a Class 2 General Hospital device with product code FXY cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K904276 · Anago, Inc. · General Hospital
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Nov 1990
Decision
63d
Days
Class 2
Risk

K904276 is an FDA 510(k) clearance for the DISPOSABLE BEARD COVER. Classified as Hood, Surgical (product code FXY), Class II - Special Controls.

Submitted by Anago, Inc. (Fort Worth, US). The FDA issued a Cleared decision on November 21, 1990 after a review of 63 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 Anago, Inc. devices

FDA 510(k) Submission Details - K904276

510(k) Number K904276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1990
Decision Date November 21, 1990
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXY Device Classification - Class 2, Special Controls

Product Code FXY Hood, 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 - FXY Hood, Surgical

All 7
Devices cleared under the same product code (FXY) and FDA review panel - the closest regulatory comparables to K904276.
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
K222214 · Thi Total Healthcare Innovation GmbH · Oct 2023
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
K200493 · Stryker Corporation · Mar 2020
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
K140588 · Stryker Corporation · Jun 2014
HOOD, CLARION SURGEONS
K770261 · Sherwood Medical Industries · Mar 1977
HOOD & BEARD COVER, CLARION SURGEON'S
K770257 · Sherwood Medical Industries · Feb 1977
BARRIER SURGICAL HOOD
K760855 · Surgikos, Inc. · Nov 1976