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FDA 510(k)

Nitrile Glove Powder Free White

K-Number: K183068 · 2018-12-21

Decision Date2018-12-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Glove Powder Free White is the device name listed in this FDA 510(k) record. The listed applicant is Haining Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K183068. 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 Nitrile Glove Powder Free White?

Nitrile Glove Powder Free White is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Haining Medical Products Co., Ltd.. The 510(k) number is K183068.

When did Nitrile Glove Powder Free White receive FDA 510(k) clearance?

Nitrile Glove Powder Free White received FDA 510(k) clearance on 2018-12-21, under 510(k) number K183068.

Who is the listed applicant for Nitrile Glove Powder Free White?

The FDA 510(k) record lists Haining Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Glove Powder Free White?

The FDA product code for Nitrile Glove Powder Free White is LZA.

Other records listing Haining Medical Products Co., Ltd. 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.

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.

Official Source

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