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FDA 510(k)

POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES

K-Number: K120963 · 2012-06-29

ApplicantMedtexx Manufacturing Sdn. Bhd.
Decision Date2012-06-29
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Medtexx Manufacturing Sdn. Bhd.. It received FDA 510(k) clearance on 2012-06-29 under 510(k) number K120963. 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 NATURAL RUBBER LATEX EXAMINATION GLOVES?

POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2012-06-29. The listed applicant is Medtexx Manufacturing Sdn. Bhd.. The 510(k) number is K120963.

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

POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES received FDA 510(k) clearance on 2012-06-29, under 510(k) number K120963.

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

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

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

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

Related Clinical Trials

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.

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Other records listing Medtexx Manufacturing 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.

K071740CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVESK070821POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLEK070072NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES

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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