FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
EAJ
Apron, Leaded
1
Product Code
EAK
Screen, Leaded, Operator Radiation Protector
1
Product Code
IWO
Apron, Protective
1
Product Code
IWP
Radiographic Protective Glove
1
Product Code
K
92
0538
PROTECTIVE RADIOGRAFIC GLOVE
1
Cleared 510(K)
K
90
4878
SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
1
Cleared 510(K)
K
90
5086
HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES
1
Cleared 510(K)
K
90
0972
RADIATION PROTECTION GLOVES
1
Cleared 510(K)
K
84
4683
IMAGEN CHLAMYDIA TEST
1
Cleared 510(K)
IWQ
Curtain, Protective, Radiographic
1
Product Code
IWR
Holder, Syringe, Lead
1
Product Code
IWS
Shield, Eye, Radiological
1
Product Code
IWT
Shield, Gonadal
1
Product Code
IWW
Shield, Vial
1
Product Code
IWX
Barrier, Control Panel, X-Ray, Movable
1
Product Code
KPY
Shield, Protective, Personnel
1
Product Code
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 May 2025 at 11:05 pm
RA
/
subpart-g—miscellaneous-devices
/
IWP
/
K920538
View Source
PROTECTIVE RADIOGRAFIC GLOVE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K920538
510(k) Type
Traditional
Applicant
BURKHART ROENTGEN INTL., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/29/1992
Days to Decision
114 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous Devices
EAJ
Apron, Leaded
EAK
Screen, Leaded, Operator Radiation Protector
IWO
Apron, Protective
IWP
Radiographic Protective Glove
K
92
0538
PROTECTIVE RADIOGRAFIC GLOVE
K
90
4878
SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
K
90
5086
HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES
K
90
0972
RADIATION PROTECTION GLOVES
K
84
4683
IMAGEN CHLAMYDIA TEST
IWQ
Curtain, Protective, Radiographic
IWR
Holder, Syringe, Lead
IWS
Shield, Eye, Radiological
IWT
Shield, Gonadal
IWW
Shield, Vial
IWX
Barrier, Control Panel, X-Ray, Movable
KPY
Shield, Protective, Personnel
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
subpart-g—miscellaneous-devices
/
IWP
/
K920538
View Source
PROTECTIVE RADIOGRAFIC GLOVE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K920538
510(k) Type
Traditional
Applicant
BURKHART ROENTGEN INTL., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/29/1992
Days to Decision
114 days
Submission Type
Statement