FDA 510(k)

Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)

K-번호: K222733 · 2022-12-11

신청자Inner Mongolia Boming Medical Supplies Co., Ltd.

결정일2022-12-11

제품 코드LZA

자문 위원회HO

결정Substantially Equivalent

기기 요약

Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) is the device name listed in this FDA 510(k) record. The listed applicant is Inner Mongolia Boming Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2022-12-11 under 510(k) number K222733. 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 Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)?

Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) is a medical device that received FDA 510(k) clearance on 2022-12-11. The listed applicant is Inner Mongolia Boming Medical Supplies Co., Ltd.. The 510(k) number is K222733.

When did Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) receive FDA 510(k) clearance?

Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) received FDA 510(k) clearance on 2022-12-11, under 510(k) number K222733.

Who is the listed applicant for Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)?

The FDA 510(k) record lists Inner Mongolia Boming Medical Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)?

The FDA product code for Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) is LZA.

Inner Mongolia Boming Medical Supplies Co., Ltd.를 신청인으로 등재한 기타 기록

K212467Disposable Nitrile Examination Glove

관련 기기 (코드: LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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