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FDA 510(k)

Disposable Nitrile Examination Glove

K-Number: K212661 · 2021-11-19

ApplicantInner Mongolia Cureguard Medical Technology Co., Ltd.
Decision Date2021-11-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Nitrile Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Inner Mongolia Cureguard Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K212661. 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 Disposable Nitrile Examination Glove?

Disposable Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Inner Mongolia Cureguard Medical Technology Co., Ltd.. The 510(k) number is K212661.

When did Disposable Nitrile Examination Glove receive FDA 510(k) clearance?

Disposable Nitrile Examination Glove received FDA 510(k) clearance on 2021-11-19, under 510(k) number K212661.

Who is the listed applicant for Disposable Nitrile Examination Glove?

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

What is the FDA product code for Disposable Nitrile Examination Glove?

The FDA product code for Disposable Nitrile Examination Glove is LZA.

Other records listing Inner Mongolia Cureguard Medical Technology 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.

K222642Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)K212401Disposable Nitrile Examination Glove

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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