FDA 510(k)

NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES

K-Number: K070072 · 2007-03-15

ApplicantMedtexx Manufacturing Sdn. Bhd.

Decision Date2007-03-15

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL 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 2007-03-15 under 510(k) number K070072. 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 NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES?

NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2007-03-15. The listed applicant is Medtexx Manufacturing Sdn. Bhd.. The 510(k) number is K070072.

When did NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES receive FDA 510(k) clearance?

NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES received FDA 510(k) clearance on 2007-03-15, under 510(k) number K070072.

Who is the listed applicant for NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL 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 NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES?

The FDA product code for NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES is LYY.

Related Clinical Trials

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Other records listing Medtexx Manufacturing Sdn. Bhd. as applicant

K120963POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES K071740CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES K070821POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE

Related Devices (Code: LYY)

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 Limited K230573Powder 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 Bhd K223298Sterile 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.