Cleared Traditional

K911447 - LATEX EXAMINATION GLOVES (HYPOALLERGENIC)

K911447 is an FDA 510(k) clearance for LATEX EXAMINATION GLOVES (HYPOALLERGENIC), 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 39-day FDA review.

K911447 · Aladan Corp. · General Hospital
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Apr 1991
Decision
39d
Days
Class 1
Risk

K911447 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVES (HYPOALLERGENIC). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Aladan Corp. (Norcross, US). The FDA issued a Cleared decision on April 16, 1991 after a review of 39 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 - K911447

510(k) Number K911447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1991
Decision Date April 16, 1991
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 K911447.
LATEX EXAMINATION GLOVES
K913409 · Top Glove Sdn. Bhd. · Sep 1991
LATEX EXAMINATION GLOVES
K912988 · La Glove (M) Sdn. Bhd. · Aug 1991
ALADAN LATEX MEDICAL GLOVE
K911774 · Aladan Corp. · May 1991
LATEX PATIENT EXAMINATION GLOVES
K911081 · Medical Device Inspection Co., Inc. · Mar 1991
ALADERM
K905678 · Aladan Corp. · Jan 1991
PATIENT EXAMINATION GLOVES
K905551 · Johnson & Johnson Medical, Inc. · Jan 1991