FDA 510(k)

Disposable Nitrile Medical Examination Glove

K-Nummer: K210691 · 2021-07-30

AntragstellerJiangsu Cureguard Glove Co., Ltd.

Entscheidungsdatum2021-07-30

ProduktcodeLZA

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

Disposable Nitrile Medical Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Cureguard Glove Co., Ltd.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K210691. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Disposable Nitrile Medical Examination Glove?

Disposable Nitrile Medical Examination Glove is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Jiangsu Cureguard Glove Co., Ltd.. The 510(k) number is K210691.

When did Disposable Nitrile Medical Examination Glove receive FDA 510(k) clearance?

Disposable Nitrile Medical Examination Glove received FDA 510(k) clearance on 2021-07-30, under 510(k) number K210691.

Who is the listed applicant for Disposable Nitrile Medical Examination Glove?

The FDA 510(k) record lists Jiangsu Cureguard Glove Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Nitrile Medical Examination Glove?

The FDA product code for Disposable Nitrile Medical Examination Glove is LZA.

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Weitere Einträge mit Jiangsu Cureguard Glove Co., Ltd. als Antragsteller

K222937Disposable Nitrile Examination Glove K213121Disposable Nitrile Examination Glove K211354Disposable Synthetic Vinyl Nitrile Examination Glove K211608Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)K210684Disposable Nitrile Medical Examination Glove

Verwandte Geräte (Code: LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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