FDA 510(k)

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)

K-번호: K162924 · 2017-01-24

결정일2017-01-24

제품 코드LZA

자문 위원회HO

결정Substantially Equivalent

기기 요약

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega Sdb. Bhd.. It received FDA 510(k) clearance on 2017-01-24 under 510(k) number K162924. 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 Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)?

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) is a medical device that received FDA 510(k) clearance on 2017-01-24. The listed applicant is Hartalega Sdb. Bhd.. The 510(k) number is K162924.

When did Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) receive FDA 510(k) clearance?

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) received FDA 510(k) clearance on 2017-01-24, under 510(k) number K162924.

Who is the listed applicant for Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)?

The FDA 510(k) record lists Hartalega Sdb. 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 Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)?

The FDA product code for Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) is LZA.

Hartalega Sdb. Bhd.를 신청인으로 등재한 기타 기록

K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)

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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