{"publicDeviceRecordKey":"16342368-37a7-4b61-9590-73308b1537bb","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2020-04-08T00:00:00.000Z","devicePublishDate":"2020-03-31T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00612479216624","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00612479216617","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"00612479216617","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00612479216600","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"McKesson","versionModelNumber":"14-34070","catalogNumber":null,"dunsNumber":"023904428","companyName":"MCKESSON MEDICAL-SURGICAL INC.","deviceCount":40,"deviceDescription":"Confiderm Latex Surgical Gloves CHEMO TESTED size7\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":true,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"59061","gmdnPTName":"Radiation attenuating Hevea-latex surgical/procedural glove","gmdnPTDefinition":"A sterile device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical/procedural site; its inner surface is not powdered and the glove's material matrix contains radiation attenuating material intended to limit wearer exposure to incident radiation (e.g., during fluoroscopy). It is used mainly as a two-way barrier to protect patient and staff from contaminants. It will have appropriate characteristics regarding tactility, and should provide appropriate physical properties (e.g., tensile strength, elasticity) and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KGO","productCodeName":"Surgeon'S Gloves"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}