FDA 510(k)

Palm Care Blue Nitrile Examination Gloves Powder Free

Numéro K : K202384 · 2020-12-02

Date de décision2020-12-02

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Palm Care Blue Nitrile Examination Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Care Thai Gloves Co. , Ltd.. It received FDA 510(k) clearance on 2020-12-02 under 510(k) number K202384. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Palm Care Blue Nitrile Examination Gloves Powder Free?

Palm Care Blue Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2020-12-02. The listed applicant is Hi-Care Thai Gloves Co. , Ltd.. The 510(k) number is K202384.

When did Palm Care Blue Nitrile Examination Gloves Powder Free receive FDA 510(k) clearance?

Palm Care Blue Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2020-12-02, under 510(k) number K202384.

Who is the listed applicant for Palm Care Blue Nitrile Examination Gloves Powder Free?

The FDA 510(k) record lists Hi-Care Thai Gloves Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Palm Care Blue Nitrile Examination Gloves Powder Free?

The FDA product code for Palm Care Blue Nitrile Examination Gloves Powder Free is LZA.

Essais cliniques associés

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Autres dossiers indiquant Hi-Care Thai Gloves Co. , Ltd. en tant que demandeur

K202377Palm Care Latex Examination Powder Free Gloves

Dispositifs connexes (Code : 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.

Source officielle

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