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FDA 510(k)

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)

K-Number: K211310 · 2021-06-16

ApplicantMegine Industries Sdn Bhd
Decision Date2021-06-16
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) is the device name listed in this FDA 510(k) record. The listed applicant is Megine Industries Sdn Bhd. It received FDA 510(k) clearance on 2021-06-16 under 510(k) number K211310. 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 AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)?

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) is a medical device that received FDA 510(k) clearance on 2021-06-16. The listed applicant is Megine Industries Sdn Bhd. The 510(k) number is K211310.

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

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) received FDA 510(k) clearance on 2021-06-16, under 510(k) number K211310.

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

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

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

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

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.

NCT07247825Efficacy of Therapeutic Percutaneous Electrolysis Simple vs Multifiliar Therapy in Supraspinatus Tendinopathy.RECRUITINGNCT07695792Efficacy of Therapeutic Percutaneous Electrolysis Simple vs Multiple vs Laser Therapy in Supraspinatus Tendinopathy.COMPLETED

Other records listing Megine Industries Sdn Bhd as applicant

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.

K220232Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange

Related Devices (Code: LZA)

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.

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 LimitedK260867Nitrile 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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