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FDA 510(k)

MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES

K-Number: K110250 · 2011-10-14

ApplicantTotal Gloves Sdn Bhd
Decision Date2011-10-14
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Total Gloves Sdn Bhd. It received FDA 510(k) clearance on 2011-10-14 under 510(k) number K110250. 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 MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES?

MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2011-10-14. The listed applicant is Total Gloves Sdn Bhd. The 510(k) number is K110250.

When did MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES receive FDA 510(k) clearance?

MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES received FDA 510(k) clearance on 2011-10-14, under 510(k) number K110250.

Who is the listed applicant for MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES?

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

What is the FDA product code for MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES?

The FDA product code for MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES is LYY.

Related Clinical Trials

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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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