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FDA 510(k)

U-MED Powder Free Polyethylene Examination Gloves,Blue Color

K-Number: K173228 · 2018-02-20

ApplicantJiangsu U-Med Rubber & Plastic Products Co., Ltd.
Decision Date2018-02-20
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

U-MED Powder Free Polyethylene Examination Gloves,Blue Color is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu U-Med Rubber & Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2018-02-20 under 510(k) number K173228. 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 U-MED Powder Free Polyethylene Examination Gloves,Blue Color?

U-MED Powder Free Polyethylene Examination Gloves,Blue Color is a medical device that received FDA 510(k) clearance on 2018-02-20. The listed applicant is Jiangsu U-Med Rubber & Plastic Products Co., Ltd.. The 510(k) number is K173228.

When did U-MED Powder Free Polyethylene Examination Gloves,Blue Color receive FDA 510(k) clearance?

U-MED Powder Free Polyethylene Examination Gloves,Blue Color received FDA 510(k) clearance on 2018-02-20, under 510(k) number K173228.

Who is the listed applicant for U-MED Powder Free Polyethylene Examination Gloves,Blue Color?

The FDA 510(k) record lists Jiangsu U-Med Rubber & Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U-MED Powder Free Polyethylene Examination Gloves,Blue Color?

The FDA product code for U-MED Powder Free Polyethylene Examination Gloves,Blue Color is LZA.

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

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