FDA 510(k)

메디스포 레이버 수술 장갑, 메디스포 폴리이소프레인 수술 장갑

K-번호: K203483 · 2021-02-01

결정일2021-02-01

제품 코드KGO

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Hbm Health Protections, Inc.. It received FDA 510(k) clearance on 2021-02-01 under 510(k) number K203483. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves?

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves is a medical device that received FDA 510(k) clearance on 2021-02-01. The listed applicant is Guilin Hbm Health Protections, Inc.. The 510(k) number is K203483.

When did Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves receive FDA 510(k) clearance?

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves received FDA 510(k) clearance on 2021-02-01, under 510(k) number K203483.

Who is the listed applicant for Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves?

The FDA 510(k) record lists Guilin Hbm Health Protections, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves?

The FDA product code for Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves is KGO.

Guilin Hbm Health Protections, Inc.를 신청인으로 등재한 기타 기록

K221748메디스포 레이버 수술 장갑, 메디스포 폴리이소프레인 수술 장갑

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