Cleared Traditional

K905086 - HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES (FDA 510(k) Clearance)

Class I Radiology device.

K905086 · Hpi, Inc. · Radiology device
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Dec 1990
Decision
19d
Days
Class 1
Risk

K905086 is an FDA 510(k) clearance for the HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES. Classified as Radiographic Protective Glove (product code IWP), Class I - General Controls.

Submitted by Hpi, Inc. (Newton Centre, US). The FDA issued a Cleared decision on December 3, 1990 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.6500 - the FDA radiology and imaging software oversight 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 Hpi, Inc. devices

Submission Details

510(k) Number K905086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1990
Decision Date December 03, 1990
Days to Decision 19 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 107d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWP Radiographic Protective Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.6500
Definition A Protective Radiographic Glove Is A "personnel Protective Shield." The Gloves Are Intended To Protect The Operator, Patient, Or Other Person From Unnecessary Exposure To Radiation During Radiological Procedures By Providing An Attenuating Barrier To Radiation. Note: These Devices Are Not Patient Examination Gloves Or Surgeon's Gloves. -
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.