FDA 510(k)

JR.MEDIK 레이저 수술 장갑 무분말

K-번호: K192328 · 2020-03-10

신청자Jr Engineering & Medical Technologies (M) Sdn. Bhd.

결정일2020-03-10

제품 코드KGO

자문 위원회SU

결정Substantially Equivalent

기기 요약

JR.MEDIK Latex Surgeon’s Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2020-03-10 under 510(k) number K192328. 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 JR.MEDIK Latex Surgeon’s Gloves Powder Free?

JR.MEDIK Latex Surgeon’s Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2020-03-10. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K192328.

When did JR.MEDIK Latex Surgeon’s Gloves Powder Free receive FDA 510(k) clearance?

JR.MEDIK Latex Surgeon’s Gloves Powder Free received FDA 510(k) clearance on 2020-03-10, under 510(k) number K192328.

Who is the listed applicant for JR.MEDIK Latex Surgeon’s Gloves Powder Free?

The FDA 510(k) record lists Jr Engineering & Medical Technologies (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JR.MEDIK Latex Surgeon’s Gloves Powder Free?

The FDA product code for JR.MEDIK Latex Surgeon’s Gloves Powder Free is KGO.

Jr Engineering & Medical Technologies (M) Sdn. Bhd.를 신청인으로 등재한 기타 기록

K222350Sterile Nitrile Surgical Gloves Powder Free K221626제주메디칼 블루 니트림 검사 장갑 무분말, 화학요법 약물 및 페닐페닐아세톤산에 사용 가능 검증 K222348JR MEDIC K221169JR MEDIC 니트림 검사 장갑 무분말- 검정 K222349JR MEDIC 니트림 검사 장갑 무분말 (오렌지, 보라)K221157JR 메디칭

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