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FDA 510(k)

Nitrile Patient Examination Gloves

K-Number: K211012 · 2021-07-23

ApplicantHuayuan Medical Technology(Shangqiu) Co., Ltd.
Decision Date2021-07-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Huayuan Medical Technology(Shangqiu) Co., Ltd.. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K211012. 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 Patient Examination Gloves?

Nitrile Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Huayuan Medical Technology(Shangqiu) Co., Ltd.. The 510(k) number is K211012.

When did Nitrile Patient Examination Gloves receive FDA 510(k) clearance?

Nitrile Patient Examination Gloves received FDA 510(k) clearance on 2021-07-23, under 510(k) number K211012.

Who is the listed applicant for Nitrile Patient Examination Gloves?

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

What is the FDA product code for Nitrile Patient Examination Gloves?

The FDA product code for Nitrile Patient Examination Gloves is LZA.

Other records listing Huayuan Medical Technology(Shangqiu) 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.

K213048Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)K211028Nitrile Patient Examination Gloves

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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