FDA 510(k)

SafeSource 디렉트 블루 파우더 프리 니트릴 검사 장갑 (AMERI-TUFF 시리즈 4000, AMERI-TOUCH 시리즈 5000)

K-번호: K250502 · 2025-03-19

결정일2025-03-19

제품 코드LZA

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) is the device name listed in this FDA 510(k) record. The listed applicant is Safesource Direct, LLC. It received FDA 510(k) clearance on 2025-03-19 under 510(k) number K250502. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)?

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) is a medical device that received FDA 510(k) clearance on 2025-03-19. The listed applicant is Safesource Direct, LLC. The 510(k) number is K250502.

When did SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) receive FDA 510(k) clearance?

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) received FDA 510(k) clearance on 2025-03-19, under 510(k) number K250502.

Who is the listed applicant for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)?

The FDA 510(k) record lists Safesource Direct, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)?

The FDA product code for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) is LZA.

Safesource Direct, LLC를 신청인으로 등재한 기타 기록

K222898SafeSource 디렉트 블루 포워드리스 니트림 검사 장갑 K221134이어줄이 달린 마스크와 테이프가 달린 수술 마스크

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.