FDA 510(k)

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)

K-Number: K163126 · 2017-02-22

Decision Date2017-02-22

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sail Medical Co.,Ltd. It received FDA 510(k) clearance on 2017-02-22 under 510(k) number K163126. 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 Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)?

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) is a medical device that received FDA 510(k) clearance on 2017-02-22. The listed applicant is Blue Sail Medical Co.,Ltd. The 510(k) number is K163126.

When did Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) received FDA 510(k) clearance on 2017-02-22, under 510(k) number K163126.

Who is the listed applicant for Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)?

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

What is the FDA product code for Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)?

The FDA product code for Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) is LZA.

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Other records listing Blue Sail Medical Co.,Ltd as applicant

K171782Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs

Related Devices (Code: LZA)

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 Limited K260867Nitrile 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.