FDA 510(k)

Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs

K-번호: K201774 · 2020-09-16

결정일2020-09-16

제품 코드KGO

자문 위원회SU

결정Substantially Equivalent

기기 요약

Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Medisafe Technologies. It received FDA 510(k) clearance on 2020-09-16 under 510(k) number K201774. 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 Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs?

Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2020-09-16. The listed applicant is Pt. Medisafe Technologies. The 510(k) number is K201774.

When did Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2020-09-16, under 510(k) number K201774.

Who is the listed applicant for Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Pt. Medisafe Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs?

The FDA product code for Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs is KGO.

Pt. Medisafe Technologies를 신청인으로 등재한 기타 기록

K182176Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs K173258Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy K163041Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E

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