Cleared Traditional

YULEX LATEX POWDER-FREE EXAM GLOVES (K063810) - FDA 510(k) Clearance

Class I General Hospital device.

K063810 · Yulex Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
483d
Days
Class 1
Risk

K063810 is an FDA 510(k) clearance for the YULEX LATEX POWDER-FREE EXAM GLOVES. Classified as Powder-free Guayle Rubber Examination Glove (product code OIG), Class I - General Controls.

Submitted by Yulex Corporation (Maricopa, US). The FDA issued a Cleared decision on April 18, 2008 after a review of 483 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Yulex Corporation devices

Submission Details

510(k) Number K063810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2006
Decision Date April 18, 2008
Days to Decision 483 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
354d slower than avg
Panel avg: 129d · This submission: 483d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OIG Powder-free Guayle Rubber Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Patient Examination Glove Made From Guayule Natural Rubber Latex. This Alternative Source Of Natural Rubber Latex (guayale) Does Not Contain The Same Protein Associated With Allergic Reactions To Latex Products From The Hevea Rubber Tree. This Device 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.