FDA 510(k)

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White

Numéro K : K212482 · 2022-08-09

DemandeurSri Trang Gloves (Thailand) Public Company Limited

Date de décision2022-08-09

Code produitLYY

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White 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 2022-08-09 under 510(k) number K212482. 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 Ocean Blue, Violet Blue, Black and Natural White?

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White is a medical device that received FDA 510(k) clearance on 2022-08-09. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. The 510(k) number is K212482.

When did Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White receive FDA 510(k) clearance?

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White received FDA 510(k) clearance on 2022-08-09, under 510(k) number K212482.

Who is the listed applicant for Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White?

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 Ocean Blue, Violet Blue, Black and Natural White?

The FDA product code for Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White is LYY.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 K212309Non-sterile, Powder-Free Latex Examination Glove 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

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.