Cleared Traditional

K952404 - SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE

K952404 is an FDA 510(k) clearance for SAFETEX SUPER HYPERALLERGENIC POWDERFRE..., 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 59-day FDA review.

K952404 · Aladan Corp. · General Hospital
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Jul 1995
Decision
59d
Days
Class 1
Risk

K952404 is an FDA 510(k) clearance for the SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE. 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 July 20, 1995 after a review of 59 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 - K952404

510(k) Number K952404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1995
Decision Date July 20, 1995
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 129d · This submission: 59d
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 K952404.
SAFESKIN
K952793 · Safeskin Corp. · Aug 1995
SAFESKIN
K952851 · Safeskin Corp. · Aug 1995
HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES
K945766 · Ansell, Inc. · Aug 1995
CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE
K952367 · Cypress Medical Products, Ltd. · Jul 1995
SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE
K952556 · Aladan Corp. · Jun 1995
ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES
K951839 · Aladan Corp. · Jun 1995