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FDA 510(k)

Powder-Free Latex examination gloves

K-Number: K222612 · 2022-11-25

ApplicantGuangdong Kingfa Sci. & Tech.Co., Ltd.
Decision Date2022-11-25
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder-Free Latex examination gloves is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2022-11-25 under 510(k) number K222612. 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 Powder-Free Latex examination gloves?

Powder-Free Latex examination gloves is a medical device that received FDA 510(k) clearance on 2022-11-25. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K222612.

When did Powder-Free Latex examination gloves receive FDA 510(k) clearance?

Powder-Free Latex examination gloves received FDA 510(k) clearance on 2022-11-25, under 510(k) number K222612.

Who is the listed applicant for Powder-Free Latex examination gloves?

The FDA 510(k) record lists Guangdong Kingfa Sci. & Tech.Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder-Free Latex examination gloves?

The FDA product code for Powder-Free Latex examination gloves is LYY.

Other records listing Guangdong Kingfa Sci. & Tech.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.

K233723Medical surgical maskK231155Biodegradable Medical surgical maskK221983Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green ColorK230046Vinyl examination glovesK222714Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy DrugsK221887Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color

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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.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.K222348JR MEDICJr Engineering & Medical Technologies (M) 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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