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FDA 510(k)

Disposable Nitrile Powder Free Examination Gloves (Non-sterile)

K-Number: K211360 · 2022-01-15

ApplicantPt. Universal Gloves
Decision Date2022-01-15
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Nitrile Powder Free Examination Gloves (Non-sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Universal Gloves. It received FDA 510(k) clearance on 2022-01-15 under 510(k) number K211360. 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 Powder Free Examination Gloves (Non-sterile)?

Disposable Nitrile Powder Free Examination Gloves (Non-sterile) is a medical device that received FDA 510(k) clearance on 2022-01-15. The listed applicant is Pt. Universal Gloves. The 510(k) number is K211360.

When did Disposable Nitrile Powder Free Examination Gloves (Non-sterile) receive FDA 510(k) clearance?

Disposable Nitrile Powder Free Examination Gloves (Non-sterile) received FDA 510(k) clearance on 2022-01-15, under 510(k) number K211360.

Who is the listed applicant for Disposable Nitrile Powder Free Examination Gloves (Non-sterile)?

The FDA 510(k) record lists Pt. Universal Gloves as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Nitrile Powder Free Examination Gloves (Non-sterile)?

The FDA product code for Disposable Nitrile Powder Free Examination Gloves (Non-sterile) 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.

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Other records listing Pt. Universal Gloves 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.

K203074Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)K201576Disposable Latex Powder Free Examination Gloves (Non-sterile)

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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