FDA 510(k)

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)

Numéro K : K182640 · 2019-04-12

DemandeurShandong Hengya Packaging Printing Co.,Ltd

Date de décision2019-04-12

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Hengya Packaging Printing Co.,Ltd. It received FDA 510(k) clearance on 2019-04-12 under 510(k) number K182640. 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 Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)?

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) is a medical device that received FDA 510(k) clearance on 2019-04-12. The listed applicant is Shandong Hengya Packaging Printing Co.,Ltd. The 510(k) number is K182640.

When did Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) received FDA 510(k) clearance on 2019-04-12, under 510(k) number K182640.

Who is the listed applicant for Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)?

The FDA 510(k) record lists Shandong Hengya Packaging Printing Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)?

The FDA product code for Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet 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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