Cleared Traditional

K905678 - ALADERM

K905678 is an FDA 510(k) clearance for ALADERM, manufactured by Aladan Corp.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K905678 · Aladan Corp. · General Hospital
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Jan 1991
Decision
30d
Days
Class 1
Risk

K905678 is an FDA 510(k) clearance for the ALADERM. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Aladan Corp. (Dothan, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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 Aladan Corp. devices

FDA 510(k) Submission Details - K905678

510(k) Number K905678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1990
Decision Date January 18, 1991
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
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 - LYY Latex Patient Examination Glove

All 402
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K905678.
ALADAN LATEX MEDICAL GLOVE
K911774 · Aladan Corp. · May 1991
LATEX EXAMINATION GLOVES (HYPOALLERGENIC)
K911447 · Aladan Corp. · Apr 1991
LATEX PATIENT EXAMINATION GLOVES
K911081 · Medical Device Inspection Co., Inc. · Mar 1991
PATIENT EXAMINATION GLOVES
K905551 · Johnson & Johnson Medical, Inc. · Jan 1991
PATIENT EXAMINATION GLOVES
K905550 · Medical Device Inspection Co., Inc. · Dec 1990
PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER)
K903107 · Ansell, Inc. · Aug 1990