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FDA 510(k)

Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove

Número K: K161929 · 2017-03-29

RequerenteDipped Products (Thailand) Limited
Data da decisão2017-03-29
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Dipped Products (Thailand) Limited. It received FDA 510(k) clearance on 2017-03-29 under 510(k) number K161929. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove?

Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove is a medical device that received FDA 510(k) clearance on 2017-03-29. The listed applicant is Dipped Products (Thailand) Limited. The 510(k) number is K161929.

When did Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove receive FDA 510(k) clearance?

Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove received FDA 510(k) clearance on 2017-03-29, under 510(k) number K161929.

Who is the listed applicant for Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove?

The FDA 510(k) record lists Dipped Products (Thailand) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove?

The FDA product code for Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove is LZA.

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Dispositivos Relacionados (Código: LZA)

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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 CitrateCardinalhealthK260794NON-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 BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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