Cleared Traditional

K904878 - SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. (FDA 510(k) Clearance)

Class I Radiology device.

K904878 · Hpi, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
128d
Days
Class 1
Risk

K904878 is an FDA 510(k) clearance for the SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.. 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 March 7, 1991 after a review of 128 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hpi, Inc. devices

Submission Details

510(k) Number K904878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1990
Decision Date March 07, 1991
Days to Decision 128 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 107d · This submission: 128d
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.