FDA 510(k)

Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)

Numéro K : K221374 · 2022-10-26

DemandeurHebei Titans Hongsen Medical Technology Co., Ltd.

Date de décision2022-10-26

Code produitLYY

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K221374. 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 Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)?

Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K221374.

When did Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) receive FDA 510(k) clearance?

Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) received FDA 510(k) clearance on 2022-10-26, under 510(k) number K221374.

Who is the listed applicant for Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)?

The FDA 510(k) record lists Hebei Titans Hongsen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)?

The FDA product code for Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) is LYY.

Essais cliniques associés

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Autres dossiers indiquant Hebei Titans Hongsen Medical Technology Co., Ltd. en tant que demandeur

K240361Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)K223895Disposable Medical Nitrile Examination Gloves K212097Disposable medical surgical mask K211229Vinyl compound examination gloves K182043Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)K181130Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs

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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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