FDA 510(k)

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)

K-번호: K232614 · 2024-05-13

신청자Sri Trang Gloves (Thailand) Public Company Limited

결정일2024-05-13

제품 코드LZA

자문 위원회HO

결정Substantially Equivalent

기기 요약

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. It received FDA 510(k) clearance on 2024-05-13 under 510(k) number K232614. 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 Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)?

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) is a medical device that received FDA 510(k) clearance on 2024-05-13. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. The 510(k) number is K232614.

When did Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) receive FDA 510(k) clearance?

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) received FDA 510(k) clearance on 2024-05-13, under 510(k) number K232614.

Who is the listed applicant for Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)?

The FDA 510(k) record lists Sri Trang Gloves (Thailand) Public Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)?

The FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) is LZA.

Sri Trang Gloves (Thailand) Public Company Limited를 신청인으로 등재한 기타 기록

K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)K240930Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue K221165Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl K212482Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White K212309Non-sterile, Powder-Free Latex Examination Glove K200539Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl

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