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FDA 510(k)

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

K-Number: K221374 · 2022-10-26

ApplicantHebei Titans Hongsen Medical Technology Co., Ltd.
Decision Date2022-10-26
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Hebei Titans Hongsen Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 GlovesK212097Disposable medical surgical maskK211229Vinyl compound examination glovesK182043Single-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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Related Devices (Code: LYY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 LimitedK230573Powder 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 BhdK223298Sterile 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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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