{"publicDeviceRecordKey":"ff2c0ec9-5516-4118-b986-3a808d52d967","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-07-06T00:00:00.000Z","devicePublishDate":"2023-06-28T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08905159002139","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Nulife","versionModelNumber":"Elbow length Gynaecology gloves - 7.5","catalogNumber":"ELGLUE","dunsNumber":"650986016","companyName":"MRK HEALTHCARE PRIVATE LIMITED","deviceCount":1,"deviceDescription":"Elbow Length gynaecology gloves are sterile, anatomically shaped medical gloves with the thumb positioned towards the palmer surface of the index finger rather than lying flat with length till elbow. These gloves are powder-free. The Elbow length gynaecology gloves are intended for use various gynecological procedures.","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":false,"contacts":{"customerContact":[{"phone":"+912262611111","phoneExtension":null,"email":"regulatory@mrkhealthcare.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K210969","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47178","gmdnPTName":"Hevea-latex surgical glove, non-powdered, non-antimicrobial","gmdnPTDefinition":"A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KGO","productCodeName":"Surgeon'S Gloves"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"7.5"}]},"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}