Cleared Traditional

K884295 - SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE

K884295 is an FDA 510(k) clearance for SURGICAL APPAREL, manufactured by Saybrex Intl., Inc.. The device is a Class 2 General Hospital device with product code LGM cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K884295 · Saybrex Intl., Inc. · General Hospital
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Nov 1988
Decision
27d
Days
Class 2
Risk

K884295 is an FDA 510(k) clearance for the SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE. Classified as Chamber, Patient Isolation (product code LGM), Class II - Special Controls.

Submitted by Saybrex Intl., Inc. (Beverly Hills, US). The FDA issued a Cleared decision on November 8, 1988 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5450 - 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 Saybrex Intl., Inc. devices

FDA 510(k) Submission Details - K884295

510(k) Number K884295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1988
Decision Date November 08, 1988
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGM Device Classification - Class 2, Special Controls

Product Code LGM Chamber, Patient Isolation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5450
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 - LGM Chamber, Patient Isolation

All 9
Devices cleared under the same product code (LGM) and FDA review panel - the closest regulatory comparables to K884295.
PATIENT ISOLATION UNIT, MODEL G019-1000
K080117 · Gentex Corporation · Jan 2009
MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
K912444 · Radiometer America, Inc. · Feb 1992
MODEL 7-AT TREATMENT CHAMBER
K896721 · J. H. Emerson Co. · Jan 1990
INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE
K874306 · Busse Hospital Disposables, Inc. · Mar 1988
ANAGO ISOLATION MASK (#80-950)
K864116 · Anago, Inc. · Nov 1986
ISOLATION MASK I.C.S.
K831062 · American Threshold Industries, Inc. · Apr 1983