FDA 510(k)

Powder free nitrile examination glove- blue, non-sterile

Número K: K212804 · 2021-12-01

Data da decisão2021-12-01

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Powder free nitrile examination glove- blue, non-sterile is the device name listed in this FDA 510(k) record. The listed applicant is Hong Seng Gloves Sdn Bhd. It received FDA 510(k) clearance on 2021-12-01 under 510(k) number K212804. 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 Powder free nitrile examination glove- blue, non-sterile?

Powder free nitrile examination glove- blue, non-sterile is a medical device that received FDA 510(k) clearance on 2021-12-01. The listed applicant is Hong Seng Gloves Sdn Bhd. The 510(k) number is K212804.

When did Powder free nitrile examination glove- blue, non-sterile receive FDA 510(k) clearance?

Powder free nitrile examination glove- blue, non-sterile received FDA 510(k) clearance on 2021-12-01, under 510(k) number K212804.

Who is the listed applicant for Powder free nitrile examination glove- blue, non-sterile?

The FDA 510(k) record lists Hong Seng Gloves Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder free nitrile examination glove- blue, non-sterile?

The FDA product code for Powder free nitrile examination glove- blue, non-sterile is LZA.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Hong Seng Gloves Sdn Bhd como candidato(a)

K221164Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl K212801Powder free nitrile examination glove- black, non sterile K212802powder free nitrile examination glove - white, non-sterile

Dispositivos Relacionados (Código: 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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.