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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 a medical device manufactured by Hl Rubber Industries Sdn Bhd. It received FDA 510(k) clearance on 2022-05-26 under approval 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. It is manufactured by Hl Rubber Industries Sdn Bhd. The 510(k) number is K220545.

When was Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs approved by the FDA?

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

What company makes 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 manufactured by Hl Rubber Industries Sdn Bhd.

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

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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)

Related Devices (Code: LZC)

K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health K151390Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy DrugsMaxter Glove Manufacturing Sdn Bhd K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy DrugsGmp Medicare Sdn Bhd (F25) K172642Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsCentral Medicare Sdn Bhd K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTESTCareplus (M) 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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