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CFR 876.5920に規定される、失禁患者向けの防護衣です。米国ではクラスIに分類されており、市販前届出（510(k)）が免除されているため、市販前にFDAへの届出を行うことなく販売することが可能です。","claude-sonnet-5","87008ef5345a8d1b7bb59fa184f92c8dd9c0524b21f8e54a0291845fb298c5b8","2026-08-24T01:50:05.227637+00:00",{"product_code":6,"summary_ja":640,"stats":641,"stats_hash":660,"model_name":636,"created_at":661,"updated_at":661},"510(k)は累計約60件、申請企業数は28社ですが、直近5年間の届出実績は確認されていません。不具合報告は累計約200件で、死亡2件、傷害115件、不具合64件、その他19件と傷害の割合が高く、直近5年間では約60件、最新の報告は2026年7月です。主な問題としてはLeak\u002FSplash（漏れ・飛散）、Material Disintegration（材料の分解）、Material Integrity Problem（材料の完全性の問題）が挙げられています。回収（リコール）は確認されていません。",{"pma":642,"k510":643,"as_of":646,"events":647,"recalls":654,"top_problems":656},{"latest":548,"originals":547,"supplements":547},{"total":549,"last5y":547,"latest":644,"applicants":645},"1995-05-03",28,"2026-08",{"death":648,"other":649,"total":550,"injury":650,"last5y":651,"malfunction":652,"latest_month":653},2,19,115,61,64,"2026-07",{"total":547,"last5y":547,"latest":548,"class_i":547,"class_ii":547,"class_iii":547,"top_root_causes":655},[],[657,658,659],"Leak\u002FSplash","Material Disintegration","Material Integrity Problem","04fe60cd97b74031e01eecf100435efffc5c7df1cfd2a6732cc9ad23ec4d036a","2026-08-24T04:18:34.328284+00:00",{"items":663,"total":547},[],{"items":665,"total":549},[666,672,678,682,686,689,693,695,698,702,706,709,713,716,720,724,726,729,732,735],{"k_number":52,"device_name":667,"applicant":668,"decision_date":644,"clearance_type":669,"decision_code":670,"statement_or_summary":671},"DRISTAR URINARY INCONTINENCE 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