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FDA 510(k)

Latex Examination Powder Free Gloves

K-Number: K211477 · 2021-09-20

ApplicantAspen Glove Sdn. Bhd.
Decision Date2021-09-20
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Latex Examination Powder Free Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2021-09-20 under 510(k) number K211477. 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 Latex Examination Powder Free Gloves?

Latex Examination Powder Free Gloves is a medical device that received FDA 510(k) clearance on 2021-09-20. The listed applicant is Aspen Glove Sdn. Bhd.. The 510(k) number is K211477.

When did Latex Examination Powder Free Gloves receive FDA 510(k) clearance?

Latex Examination Powder Free Gloves received FDA 510(k) clearance on 2021-09-20, under 510(k) number K211477.

Who is the listed applicant for Latex Examination Powder Free Gloves?

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

What is the FDA product code for Latex Examination Powder Free Gloves?

The FDA product code for Latex Examination Powder Free Gloves is LYY.

Other records listing Aspen Glove 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.

K213076AspenMed+K211479Blue Nitrile Examination Glove Powder FreeK211478Sterile Latex Surgical Gloves Powder Free

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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