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
- K110900DISPOSABLE THYROID COLLAR1Cleared 510(K)
- K962622INTRA-ORAL THERMOPLASTIC SHIELD1Cleared 510(K)
- K954456THERMOPLASTIC SHIELD1Cleared 510(K)
- K954146UTK-DTE AUTILARY SHIELD1Cleared 510(K)
- K953610AUKULYTE1Cleared 510(K)
- K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)1Cleared 510(K)
- K951003KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)1Cleared 510(K)
- K940539STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM1Cleared 510(K)
- K934206MAVIG ANGIO SHIELD MODELS 6290 & 62721Cleared 510(K)
- K912378DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS1Cleared 510(K)
- K912327DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS.1Cleared 510(K)
- K912326DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS1Cleared 510(K)
- K900970RADIATION PROTECTION GLASSES1Cleared 510(K)
- K896511DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL1Cleared 510(K)
- K896289RADIATION PROTECTION APRON1Cleared 510(K)
- K871502PERSONNEL PROTECTIVE SHIELD1Cleared 510(K)
- K844160VENTIBOX1Cleared 510(K)
- K811677KRYPTON CART1Cleared 510(K)
- K811068BYPASS COIL1Cleared 510(K)
- K810095MOTI APRON1Cleared 510(K)
- K802377MOTI PROTECTIVE X-RAY MASK1Cleared 510(K)
- K791522FLOW MEDICAL X-RAY PROTECTIVE GLOVES1Cleared 510(K)
- K790639GONAD SHIELD1Cleared 510(K)
- K790080APRON, LEADED VINYL1Cleared 510(K)
- K781852GLOVE, SUPERFLEX MOLDED1Cleared 510(K)
- PDKCream For X-Ray Attenuation2Product Code
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
GLOVE, SUPERFLEX MOLDED
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K781852
- 510(k) Type
- Traditional
- Applicant
- PINNACLE DISTRIBUTORS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/15/1978
- Days to Decision
- 9 days