Cleared Traditional

PROTECTIVE RADIOGRAFIC GLOVE

K920538 · Burkhart Roentgen Intl., Inc. · Radiology
May 1992
Decision
114d
Days
Class 1
Risk

About This 510(k) Submission

K920538 is an FDA 510(k) clearance for the PROTECTIVE RADIOGRAFIC GLOVE, a Radiographic Protective Glove (Class I — General Controls, product code IWP), submitted by Burkhart Roentgen Intl., Inc. (Pinellas Park, US). The FDA issued a Cleared decision on May 29, 1992, 114 days after receiving the submission on February 5, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number K920538 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 1992
Decision Date May 29, 1992
Days to Decision 114 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IWP — Radiographic Protective Glove
Device Class Class I — 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. -