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FDA 510(k)

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl

K-Number: K221082 · 2022-11-30

ApplicantRhino Health, Inc.
Decision Date2022-11-30
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl is a medical device manufactured by Rhino Health, Inc.. It received FDA 510(k) clearance on 2022-11-30 under approval number K221082. 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 Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl?

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl is a medical device that received FDA 510(k) clearance on 2022-11-30. It is manufactured by Rhino Health, Inc.. The 510(k) number is K221082.

When was Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl approved by the FDA?

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl received FDA 510(k) clearance on 2022-11-30, under approval number K221082.

What company makes Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl?

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl is manufactured by Rhino Health, Inc..

What is the FDA product code for Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl?

The FDA product code for Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl is LZA.

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Other Devices by Rhino Health, Inc.

K203236Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove K223859Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl

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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