FDA 510(k)

Non-sterile, Powder-Free Latex Examination Glove

Numéro K : K212309 · 2022-04-08

DemandeurSri Trang Gloves (Thailand) Public Company Limited

Date de décision2022-04-08

Code produitLYY

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Non-sterile, Powder-Free Latex Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K212309. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Non-sterile, Powder-Free Latex Examination Glove?

Non-sterile, Powder-Free Latex Examination Glove is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. The 510(k) number is K212309.

When did Non-sterile, Powder-Free Latex Examination Glove receive FDA 510(k) clearance?

Non-sterile, Powder-Free Latex Examination Glove received FDA 510(k) clearance on 2022-04-08, under 510(k) number K212309.

Who is the listed applicant for Non-sterile, Powder-Free Latex Examination Glove?

The FDA 510(k) record lists Sri Trang Gloves (Thailand) Public Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-sterile, Powder-Free Latex Examination Glove?

The FDA product code for Non-sterile, Powder-Free Latex Examination Glove is LYY.

Essais cliniques associés

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Autres dossiers indiquant Sri Trang Gloves (Thailand) Public Company Limited en tant que demandeur

K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)K240930Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue K232614Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)K221165Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl K212482Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White K200539Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl

Voir tous les 8 dispositifs →

Dispositifs connexes (Code : LYY)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

Source officielle

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