Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- EAJApron, Leaded1Product Code
- EAKScreen, Leaded, Operator Radiation Protector1Product Code
- IWOApron, Protective1Product Code
- IWPRadiographic Protective Glove1Product Code
- IWQCurtain, Protective, Radiographic1Product Code
- IWRHolder, Syringe, Lead1Product Code
- IWSShield, Eye, Radiological1Product Code
- IWTShield, Gonadal1Product Code
- IWWShield, Vial1Product Code
- IWXBarrier, Control Panel, X-Ray, Movable1Product Code
- KPYShield, Protective, Personnel1Product Code
- PDKCream For X-Ray Attenuation2Product Code
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PROTECTIVE RADIOGRAFIC GLOVE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 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