FDA.reportPublic FDA data

510(k) K905086

Device
HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES
Applicant
HPI, INC.
510(k) number
K905086
Product code
IWP  
Decision
Substantially Equivalent (SESE)
Decision date
1990-12-03
Date received
1990-11-14
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
JUDITH A GENZALE
Address
825 Beacon St. Suite 11 Newton Centre MA US 02159 02159

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
K900972RADIATION PROTECTION GLOVESInfab Corp.1990-05-01
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