FDA 510(k)

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)

K-Number: K210755 · 2021-05-07

Decision Date2021-05-07

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Meditech Gloves Sdn Bhd. It received FDA 510(k) clearance on 2021-05-07 under 510(k) number K210755. 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 Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)?

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) is a medical device that received FDA 510(k) clearance on 2021-05-07. The listed applicant is Meditech Gloves Sdn Bhd. The 510(k) number is K210755.

When did Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) receive FDA 510(k) clearance?

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) received FDA 510(k) clearance on 2021-05-07, under 510(k) number K210755.

Who is the listed applicant for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)?

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

What is the FDA product code for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)?

The FDA product code for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) is LZA.

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Other records listing Meditech Gloves Sdn Bhd as applicant

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Related Devices (Code: LZA)

K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet BlueHartalega NGC Sdn. Bhd.K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionSw Technologies, Inc.K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company Limited K260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)Hartalega NGC Sdn. Bhd.K260806Nitrile Disposable Examination GlovesVista Industries,, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.