FDA 510(k)

THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE

Номер K: K162626 · 2017-03-31

Дата решения2017-03-31

Код продуктаLZA

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Top Quality Glove Sdn. Bhd. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K162626. 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 THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE?

THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Top Quality Glove Sdn. Bhd. The 510(k) number is K162626.

When did THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE receive FDA 510(k) clearance?

THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE received FDA 510(k) clearance on 2017-03-31, under 510(k) number K162626.

Who is the listed applicant for THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE?

The FDA 510(k) record lists Top Quality Glove Sdn. Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE?

The FDA product code for THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE 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.

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Связанные устройства (Код: 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.

Официальный источник

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