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FDA 510(k)

SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove

K-Number: K211003 · 2022-01-19

ApplicantShowa Best Glove, Inc.
Decision Date2022-01-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Showa Best Glove, Inc.. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K211003. 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 SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove?

SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Showa Best Glove, Inc.. The 510(k) number is K211003.

When did SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove receive FDA 510(k) clearance?

SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove received FDA 510(k) clearance on 2022-01-19, under 510(k) number K211003.

Who is the listed applicant for SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove?

The FDA 510(k) record lists Showa Best Glove, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove?

The FDA product code for SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove is LZA.

Other records listing Showa Best Glove, Inc. 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.

K190159Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile gloveK180468SBG Black Nitrile Powder Free Medical Examination GloveK180467SBG Blue Nitrile Powder Free Medical 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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