FDA.reportPublic FDA data

510(k) K900972

Device
RADIATION PROTECTION GLOVES
Applicant
INFAB CORP.
510(k) number
K900972
Product code
IWP  
Decision
Substantially Equivalent (SESE)
Decision date
1990-05-01
Date received
1990-03-02
Regulation
892.6500
Classification name
Radiographic Protective Glove
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DON CUSICK
Address
3651 Via Pescador Camarillo CA US 93012 93012

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IWP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K920538PROTECTIVE RADIOGRAFIC GLOVEBurkhart Roentgen Intl., Inc.1992-05-29
K904878SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.Hpi, Inc.1991-03-07
K905086HPI TRI-RADS VINYL RADIATION PROTECTION GLOVESHpi, Inc.1990-12-03
K844683IMAGEN CHLAMYDIA TESTBoots-Celltech Diagnostics, Inc.1985-02-06

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases