Cleared Traditional

VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.) (K891567) - FDA 510(k) Clearance

Class I General Hospital device.

K891567 · Neo-Sigma, Inc. · General Hospital
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Apr 1989
Decision
25d
Days
Class 1
Risk

K891567 is an FDA 510(k) clearance for the VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Neo-Sigma, Inc. (Dallas, US). The FDA issued a Cleared decision on April 11, 1989 after a review of 25 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 Neo-Sigma, Inc. devices

Submission Details

510(k) Number K891567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date April 11, 1989
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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.