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FDA 510(k)

Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)

K-Number: K200960 · 2020-07-13

ApplicantMedline Industires, Inc.
Decision Date2020-07-13
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industires, Inc.. It received FDA 510(k) clearance on 2020-07-13 under 510(k) number K200960. 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 Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)?

Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2020-07-13. The listed applicant is Medline Industires, Inc.. The 510(k) number is K200960.

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

Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) received FDA 510(k) clearance on 2020-07-13, under 510(k) number K200960.

Who is the listed applicant for Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)?

The FDA 510(k) record lists Medline Industires, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)?

The FDA product code for Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) is LZA.

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Other records listing Medline Industires, Inc. 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.

K220955Hudson RCI Variable concentration Large Volume Nebulizer (1770)K201129Medline Smoke Evacuation PencilK201390Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)K201319Medline UNITE Jones Fracture Screw System

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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