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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 a medical device manufactured by Riverstone Resources Sdn Bhd. It received FDA 510(k) clearance on 2018-06-12 under approval 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. It is manufactured by Riverstone Resources Sdn Bhd. The 510(k) number is K180452.

When was White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim approved by the FDA?

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

What company makes White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim?

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim is manufactured by Riverstone Resources Sdn Bhd.

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 Devices by Riverstone Resources Sdn Bhd

K190725Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White K200326Powder Free Nitrile Examination Glove (Aqua Green) K220672Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim K220401Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim

Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd

Official Source

View on FDA Database →

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

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