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FDA 510(k)

Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs

K-Number: K220545 · 2022-05-26

ApplicantHl Rubber Industries Sdn Bhd
Decision Date2022-05-26
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Hl Rubber Industries Sdn Bhd. It received FDA 510(k) clearance on 2022-05-26 under 510(k) number K220545. 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 Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs?

Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is Hl Rubber Industries Sdn Bhd. The 510(k) number is K220545.

When did Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs received FDA 510(k) clearance on 2022-05-26, under 510(k) number K220545.

Who is the listed applicant for Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs?

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

What is the FDA product code for Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs?

The FDA product code for Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs is LZC.

Related Clinical Trials

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.

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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.K220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.K220353Disposal 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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