Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Nitrile Gloves (ABC-DG01)

K-Number: K230542 · 2023-05-31

ApplicantHuizhou Anboson Technology Co., Ltd.
Decision Date2023-05-31
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Nitrile Gloves (ABC-DG01) is a medical device manufactured by Huizhou Anboson Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-31 under approval number K230542. 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 Disposable Nitrile Gloves (ABC-DG01)?

Disposable Nitrile Gloves (ABC-DG01) is a medical device that received FDA 510(k) clearance on 2023-05-31. It is manufactured by Huizhou Anboson Technology Co., Ltd.. The 510(k) number is K230542.

When was Disposable Nitrile Gloves (ABC-DG01) approved by the FDA?

Disposable Nitrile Gloves (ABC-DG01) received FDA 510(k) clearance on 2023-05-31, under approval number K230542.

What company makes Disposable Nitrile Gloves (ABC-DG01)?

Disposable Nitrile Gloves (ABC-DG01) is manufactured by Huizhou Anboson Technology Co., Ltd..

What is the FDA product code for Disposable Nitrile Gloves (ABC-DG01)?

The FDA product code for Disposable Nitrile Gloves (ABC-DG01) is LZA.

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.

↑