FDA 510(k)

Disposable Nitrile Examination Gloves (Powder free, Blue)

Numéro K : K211581 · 2021-10-28

DemandeurLeping Shengde Medical Technology Company Limited

Date de décision2021-10-28

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Nitrile Examination Gloves (Powder free, Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Leping Shengde Medical Technology Company Limited. It received FDA 510(k) clearance on 2021-10-28 under 510(k) number K211581. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Disposable Nitrile Examination Gloves (Powder free, Blue)?

Disposable Nitrile Examination Gloves (Powder free, Blue) is a medical device that received FDA 510(k) clearance on 2021-10-28. The listed applicant is Leping Shengde Medical Technology Company Limited. The 510(k) number is K211581.

When did Disposable Nitrile Examination Gloves (Powder free, Blue) receive FDA 510(k) clearance?

Disposable Nitrile Examination Gloves (Powder free, Blue) received FDA 510(k) clearance on 2021-10-28, under 510(k) number K211581.

Who is the listed applicant for Disposable Nitrile Examination Gloves (Powder free, Blue)?

The FDA 510(k) record lists Leping Shengde Medical Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Nitrile Examination Gloves (Powder free, Blue)?

The FDA product code for Disposable Nitrile Examination Gloves (Powder free, Blue) is LZA.

Essais cliniques associés

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Dispositifs connexes (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.

Source officielle

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