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FDA 510(k)

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves

K-Number: K222898 · 2022-11-07

ApplicantSafesource Direct, LLC
Decision Date2022-11-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Safesource Direct, LLC. It received FDA 510(k) clearance on 2022-11-07 under 510(k) number K222898. 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 SafeSource Direct Blue Powder-Free Nitrile Exam Gloves?

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves is a medical device that received FDA 510(k) clearance on 2022-11-07. The listed applicant is Safesource Direct, LLC. The 510(k) number is K222898.

When did SafeSource Direct Blue Powder-Free Nitrile Exam Gloves receive FDA 510(k) clearance?

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves received FDA 510(k) clearance on 2022-11-07, under 510(k) number K222898.

Who is the listed applicant for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves?

The FDA 510(k) record lists Safesource Direct, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves?

The FDA product code for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves is LZA.

Other records listing Safesource Direct, LLC 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.

K250502SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)K221134Procedure Mask with Ear Loops and Surgical Mask with Ties

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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