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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 a medical device manufactured by Jiangsu U-Med Rubber & Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2018-02-20 under approval 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. It is manufactured by Jiangsu U-Med Rubber & Plastic Products Co., Ltd.. The 510(k) number is K173228.

When was U-MED Powder Free Polyethylene Examination Gloves,Blue Color approved by the FDA?

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

What company makes U-MED Powder Free Polyethylene Examination Gloves,Blue Color?

U-MED Powder Free Polyethylene Examination Gloves,Blue Color is manufactured by Jiangsu U-Med Rubber & Plastic Products Co., Ltd..

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.

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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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