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FDA 510(k)

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White

K-Number: K190725 · 2019-12-17

ApplicantRiverstone Resources Sdn Bhd
Decision Date2019-12-17
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White is a medical device manufactured by Riverstone Resources Sdn Bhd. It received FDA 510(k) clearance on 2019-12-17 under approval number K190725. 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 Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White?

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White is a medical device that received FDA 510(k) clearance on 2019-12-17. It is manufactured by Riverstone Resources Sdn Bhd. The 510(k) number is K190725.

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

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White received FDA 510(k) clearance on 2019-12-17, under approval number K190725.

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

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

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025)

Other Devices by Riverstone Resources Sdn Bhd

K180452White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim 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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