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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 a medical device manufactured by Safesource Direct, LLC. It received FDA 510(k) clearance on 2022-11-07 under approval 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. It is manufactured by Safesource Direct, LLC. The 510(k) number is K222898.

When was SafeSource Direct Blue Powder-Free Nitrile Exam Gloves approved by the FDA?

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

What company makes SafeSource Direct Blue Powder-Free Nitrile Exam Gloves?

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves is manufactured by Safesource Direct, LLC.

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.

Related Clinical Trials

NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED

Other Devices by Safesource Direct, LLC

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

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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