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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 a medical device manufactured by Pt. Universal Gloves. It received FDA 510(k) clearance on 2022-01-15 under approval 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. It is manufactured by Pt. Universal Gloves. The 510(k) number is K211360.

When was Disposable Nitrile Powder Free Examination Gloves (Non-sterile) approved by the FDA?

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

What company makes Disposable Nitrile Powder Free Examination Gloves (Non-sterile)?

Disposable Nitrile Powder Free Examination Gloves (Non-sterile) is manufactured by Pt. Universal Gloves.

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

NCT06968845 A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED

Other Devices by Pt. Universal Gloves

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

Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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