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FDA 510(k)

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim

K-Number: K180452 · 2018-06-12

ApplicantRiverstone Resources Sdn Bhd
Decision Date2018-06-12
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim is the device name listed in this FDA 510(k) record. The listed applicant is Riverstone Resources Sdn Bhd. It received FDA 510(k) clearance on 2018-06-12 under 510(k) number K180452. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim?

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim is a medical device that received FDA 510(k) clearance on 2018-06-12. The listed applicant is Riverstone Resources Sdn Bhd. The 510(k) number is K180452.

When did White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim receive FDA 510(k) clearance?

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim received FDA 510(k) clearance on 2018-06-12, under 510(k) number K180452.

Who is the listed applicant for White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim?

The FDA 510(k) record lists Riverstone Resources Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim?

The FDA product code for White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim is LZA.

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Other records listing Riverstone Resources Sdn Bhd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220672Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test ClaimK220401Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test ClaimK200326Powder Free Nitrile Examination Glove (Aqua Green)K190725Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet BlueHartalega NGC Sdn. Bhd.K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionSw Technologies, Inc.K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company LimitedK260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)Hartalega NGC Sdn. Bhd.K260806Nitrile Disposable Examination GlovesVista Industries,, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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