[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PWT":3},{"classification":4,"mappedDevices":41,"similarCandidates":42,"relatedClassifications":121,"syncDates":177},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":38,"updated_at":38,"recall_count":39,"latest_recall_date":40,"k510_count":39,"pma_count":39,"event_count":39},5663,"PWT","Chemotherapy Spill Clean-Up Kit","1","880.6250","HO","General Hospital","7","This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FMedicalDevices\u002FDeviceRegulationandGuidance\u002FGuidanceDocuments\u002Fucm080217.pdf.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":35,"device_class":8,"implant_flag":36,"product_code":6,"review_panel":10,"gmp_exempt_flag":36,"third_party_flag":36,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":35,"life_sustain_support_flag":36,"medical_specialty_description":11,"summary_malfunction_reporting":37},{"fei_number":17,"registration_number":31},[18,19,20,21,22,23,24,25,26,27,28,29,30],"3045816907","3004122598","1417592","3002902735","3001236905","3001639729","3007329020","3035642068","3014527916","3045816902","3018167761","1928237","1030451",[18,32,19,33,20,24,25,26,27,28,29,34,30],"1530671","1423537","9616088","","N","Eligible","2026-08-18T05:52:52.949882+00:00",0,null,[],[43,52,61,68,76,83,91,98,106,113],{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},4168,"歯科用口腔内清掃キット","Ⅰ","70927000",0.173077,0.123249,0.60571,0.026901,{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},1866,"温熱療法用キット","Ⅱ","70215000",0.342857,0.15051,0.568767,0.0163934,{"medical_device_id":62,"generic_name":63,"class_classification":46,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":60},3810,"薬剤なし再使用可能な救急キット","43000000",0.0506329,0.2,0.639256,{"medical_device_id":69,"generic_name":70,"class_classification":55,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},2493,"冷却療法用器具及び装置","36758000",0.204545,0.155367,0.377887,0.016129,{"medical_device_id":77,"generic_name":78,"class_classification":46,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":75},3629,"再使用可能な羊水穿刺キット","32685000",0.0740741,0.167116,0.633961,{"medical_device_id":84,"generic_name":85,"class_classification":55,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},1860,"レーザ照射療法用キット","70208020",0.196078,0.182065,0.521266,0.015873,{"medical_device_id":92,"generic_name":93,"class_classification":55,"jmdn_code":94,"name_similarity":95,"definition_similarity":96,"vector_similarity":97,"score":90},2310,"再使用可能な吸引キット","37447000",0.106383,0.183007,0.628952,{"medical_device_id":99,"generic_name":100,"class_classification":55,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},1865,"温熱療法用針","70214000",0.190476,0.15285,0.461161,0.015625,{"medical_device_id":107,"generic_name":108,"class_classification":55,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":105},1870,"子宮内組織採取キット","11531000",0.0980392,0.173804,0.628748,{"medical_device_id":114,"generic_name":115,"class_classification":55,"jmdn_code":116,"name_similarity":117,"definition_similarity":118,"vector_similarity":119,"score":120},2254,"薬剤なし単回使用救急キット","44047000",0.0759494,0.195122,0.627094,0.0153846,[122,126,130,134,138,142,146,150,153,156,159,162,165,168,171,174],{"product_code":123,"device_name":124,"device_class":8,"k510_count":125},"LYY","Latex Patient Examination Glove",1954,{"product_code":127,"device_name":128,"device_class":8,"k510_count":129},"LZA","Polymer Patient Examination Glove",1175,{"product_code":131,"device_name":132,"device_class":8,"k510_count":133},"LYZ","Vinyl Patient Examination Glove",799,{"product_code":135,"device_name":136,"device_class":8,"k510_count":137},"LZC","Medical Glove, Specialty",79,{"product_code":139,"device_name":140,"device_class":8,"k510_count":141},"FMC","Patient Examination Glove",34,{"product_code":143,"device_name":144,"device_class":8,"k510_count":145},"LZB","Finger Cot",5,{"product_code":147,"device_name":148,"device_class":8,"k510_count":149},"OIG","Powder-Free Guayle Rubber Examination Glove",1,{"product_code":151,"device_name":152,"device_class":8,"k510_count":149},"OPC","Powder-Free Polychloroprene Patient Examination Glove",{"product_code":154,"device_name":155,"device_class":8,"k510_count":39},"OPH","Radiation Attenuating Medical Glove",{"product_code":157,"device_name":158,"device_class":8,"k510_count":39},"OPJ","Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs",{"product_code":160,"device_name":161,"device_class":8,"k510_count":39},"PWP","Blood Borne Pathogen Response Kit",{"product_code":163,"device_name":164,"device_class":8,"k510_count":39},"PWS","Chemotherapy Administration Kit",{"product_code":166,"device_name":167,"device_class":8,"k510_count":39},"PWV","Delivery Room Apparel Kit",{"product_code":169,"device_name":170,"device_class":8,"k510_count":39},"PXC","Personal Protection Kit",{"product_code":172,"device_name":173,"device_class":8,"k510_count":39},"PXD","Prep Kit",{"product_code":175,"device_name":176,"device_class":8,"k510_count":39},"QDO","Fentanyl And Other Opioid  Protection Glove",{"510k":178,"classification":179,"enforcement":180,"event":181,"pma":182,"warning_letter":183},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-19T04:07:02.603+00:00"]