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FDA 510(k)

Best Glove-Nitrile Powder Free Examination Glove

K-Number: K210249 · 2021-10-25

ApplicantBestsafe Glove Co., Ltd.
Decision Date2021-10-25
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Best Glove-Nitrile Powder Free Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Bestsafe Glove Co., Ltd.. It received FDA 510(k) clearance on 2021-10-25 under 510(k) number K210249. 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 Best Glove-Nitrile Powder Free Examination Glove?

Best Glove-Nitrile Powder Free Examination Glove is a medical device that received FDA 510(k) clearance on 2021-10-25. The listed applicant is Bestsafe Glove Co., Ltd.. The 510(k) number is K210249.

When did Best Glove-Nitrile Powder Free Examination Glove receive FDA 510(k) clearance?

Best Glove-Nitrile Powder Free Examination Glove received FDA 510(k) clearance on 2021-10-25, under 510(k) number K210249.

Who is the listed applicant for Best Glove-Nitrile Powder Free Examination Glove?

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

What is the FDA product code for Best Glove-Nitrile Powder Free Examination Glove?

The FDA product code for Best Glove-Nitrile Powder Free Examination Glove is LZA.

Related Clinical Trials

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.

NCT07541976Comparative Evaluation of Three Different Pulpotomy Agents in Primary MolarsACTIVE_NOT_RECRUITING

Other records listing Bestsafe Glove 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.

K210253Best Glove-Latex Powder Free 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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