Cleared Traditional

LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING (K980827) - FDA 510(k) Clearance

Class I General Hospital device.

K980827 · Tucker & Associates · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
62d
Days
Class 1
Risk

K980827 is an FDA 510(k) clearance for the LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING. Classified as Finger Cot (product code LZB), Class I - General Controls.

Submitted by Tucker & Associates (Sparks, US). The FDA issued a Cleared decision on May 4, 1998 after a review of 62 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 Tucker & Associates devices

Submission Details

510(k) Number K980827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1998
Decision Date May 04, 1998
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZB Finger Cot
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
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.