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FDA 510(k)

Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs

K-Number: K220491 · 2022-05-14

ApplicantHainan Asther Medical Equipment Co., Ltd.
Decision Date2022-05-14
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Hainan Asther Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-05-14 under 510(k) number K220491. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs?

Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2022-05-14. The listed applicant is Hainan Asther Medical Equipment Co., Ltd.. The 510(k) number is K220491.

When did Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2022-05-14, under 510(k) number K220491.

Who is the listed applicant for Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Hainan Asther Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs?

The FDA product code for Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs is LZC.

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Related Devices (Code: LZC)

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.

K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealthK243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn BhdK220353Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy DrugsNiujian Technology Co., Ltd.

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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