FDA Product Code IWP: Radiographic Protective Glove
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. -
Leading manufacturers include Hpi, Inc., Boots-Celltech Diagnostics, Inc. and Infab Corp..
5
Total
5
Cleared
78d
Avg days
1985
Since
FDA 510(k) Cleared Radiographic Protective Glove Devices (Product Code IWP)
5 devices
Cleared
May 29, 1992
PROTECTIVE RADIOGRAFIC GLOVE
Burkhart Roentgen Intl., Inc.
Radiology
114d
Cleared
Mar 07, 1991
SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
Hpi, Inc.
Radiology
128d
Cleared
Dec 03, 1990
HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES
Hpi, Inc.
Radiology
19d
Cleared
May 01, 1990
RADIATION PROTECTION GLOVES
Infab Corp.
Radiology
60d
Cleared
Feb 06, 1985
IMAGEN CHLAMYDIA TEST
Boots-Celltech Diagnostics, Inc.
Microbiology
68d