Cleared Traditional

K900972 - RADIATION PROTECTION GLOVES (FDA 510(k) Clearance)

Class I Radiology device.

K900972 · Infab Corp. · Radiology device
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May 1990
Decision
60d
Days
Class 1
Risk

K900972 is an FDA 510(k) clearance for the RADIATION PROTECTION GLOVES. Classified as Radiographic Protective Glove (product code IWP), Class I - General Controls.

Submitted by Infab Corp. (Camarillo, US). The FDA issued a Cleared decision on May 1, 1990 after a review of 60 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 Infab Corp. devices

Submission Details

510(k) Number K900972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1990
Decision Date May 01, 1990
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
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.