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FDA 510(k)

Iconic Latex Glove

K-Number: K221648 · 2022-08-25

ApplicantIconic Medicare Sdn Bhd
Decision Date2022-08-25
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Iconic Latex Glove is the device name listed in this FDA 510(k) record. The listed applicant is Iconic Medicare Sdn Bhd. It received FDA 510(k) clearance on 2022-08-25 under 510(k) number K221648. 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 Iconic Latex Glove?

Iconic Latex Glove is a medical device that received FDA 510(k) clearance on 2022-08-25. The listed applicant is Iconic Medicare Sdn Bhd. The 510(k) number is K221648.

When did Iconic Latex Glove receive FDA 510(k) clearance?

Iconic Latex Glove received FDA 510(k) clearance on 2022-08-25, under 510(k) number K221648.

Who is the listed applicant for Iconic Latex Glove?

The FDA 510(k) record lists Iconic Medicare Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Iconic Latex Glove?

The FDA product code for Iconic Latex Glove is LYY.

Other records listing Iconic Medicare Sdn Bhd 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.

K222181Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl CitrateK212182Iconic Nitrile Glove

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

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

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