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FDA 510(k)

Powder Free Nitrile Examination Glove Black and Dual Color White-Blue

K-Nummer: K201857 · 2021-08-20

AntragstellerCareplus (M) Sdn Bhd
Entscheidungsdatum2021-08-20
ProduktcodeLZA
BeratungsausschussHO
EntscheidungSubstantially Equivalent

Produktübersicht

Powder Free Nitrile Examination Glove Black and Dual Color White-Blue is the device name listed in this FDA 510(k) record. The listed applicant is Careplus (M) Sdn Bhd. It received FDA 510(k) clearance on 2021-08-20 under 510(k) number K201857. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Powder Free Nitrile Examination Glove Black and Dual Color White-Blue?

Powder Free Nitrile Examination Glove Black and Dual Color White-Blue is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Careplus (M) Sdn Bhd. The 510(k) number is K201857.

When did Powder Free Nitrile Examination Glove Black and Dual Color White-Blue receive FDA 510(k) clearance?

Powder Free Nitrile Examination Glove Black and Dual Color White-Blue received FDA 510(k) clearance on 2021-08-20, under 510(k) number K201857.

Who is the listed applicant for Powder Free Nitrile Examination Glove Black and Dual Color White-Blue?

The FDA 510(k) record lists Careplus (M) 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 Black and Dual Color White-Blue?

The FDA product code for Powder Free Nitrile Examination Glove Black and Dual Color White-Blue is LZA.

Zugehörige klinische Studien

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Weitere Einträge mit Careplus (M) Sdn Bhd als Antragsteller

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

K211621Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)K203705Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugsK210656ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugsK202765ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugsK162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST

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Verwandte Geräte (Code: LZA)

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

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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