FDA 510(k)

Nitrile Powder Free Examination Gloves Biodegradable (Green)

K-번호: K240269 · 2024-10-25

신청자Comfort Rubber Gloves Industries Sdn. Bhd.

결정일2024-10-25

제품 코드LZA

자문 위원회HO

결정Substantially Equivalent

기기 요약

Nitrile Powder Free Examination Gloves Biodegradable (Green) is the device name listed in this FDA 510(k) record. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K240269. 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 Nitrile Powder Free Examination Gloves Biodegradable (Green)?

Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. The 510(k) number is K240269.

When did Nitrile Powder Free Examination Gloves Biodegradable (Green) receive FDA 510(k) clearance?

Nitrile Powder Free Examination Gloves Biodegradable (Green) received FDA 510(k) clearance on 2024-10-25, under 510(k) number K240269.

Who is the listed applicant for Nitrile Powder Free Examination Gloves Biodegradable (Green)?

The FDA 510(k) record lists Comfort Rubber Gloves Industries Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Powder Free Examination Gloves Biodegradable (Green)?

The FDA product code for Nitrile Powder Free Examination Gloves Biodegradable (Green) is LZA.

Comfort Rubber Gloves Industries Sdn. Bhd.를 신청인으로 등재한 기타 기록

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein K241528Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential K192954Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl K200181Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K190080Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)K180476Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

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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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