Дата решения2021-05-07
Код продуктаLZA
Консультативный комитетHO
РешениеSubstantially Equivalent
Описание устройства
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) is the device name listed in this FDA 510(k) record. The listed applicant is Central Medicare Sdn Bhd. It received FDA 510(k) clearance on 2021-05-07 under 510(k) number K203036. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Часто задаваемые вопросы
What is the Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)?
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) is a medical device that received FDA 510(k) clearance on 2021-05-07. The listed applicant is Central Medicare Sdn Bhd. The 510(k) number is K203036.
When did Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) receive FDA 510(k) clearance?
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) received FDA 510(k) clearance on 2021-05-07, under 510(k) number K203036.
Who is the listed applicant for Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)?
The FDA 510(k) record lists Central Medicare Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)?
The FDA product code for Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) is LZA.
Связанные клинические исследования
Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.
Другие записи, где Central Medicare Sdn Bhd указан как заявитель
Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.
K230681Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and FentanylK223752Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and FentanylK230875Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance ClaimsK230564Green Non Sterile Powder Free Nitrile Examination GlovesK213437Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance ClaimsK211022Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. Посмотреть все 11 устройств →
Связанные устройства (Код: LZA)
Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.
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.
Официальный источник
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