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FDA 510(k)

QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED

K-Number: K991462 · 1999-05-28

ApplicantLatexx Partners Bhd.
Decision Date1999-05-28
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED is the device name listed in this FDA 510(k) record. The listed applicant is Latexx Partners Bhd.. It received FDA 510(k) clearance on 1999-05-28 under 510(k) number K991462. 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 QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED?

QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED is a medical device that received FDA 510(k) clearance on 1999-05-28. The listed applicant is Latexx Partners Bhd.. The 510(k) number is K991462.

When did QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED receive FDA 510(k) clearance?

QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED received FDA 510(k) clearance on 1999-05-28, under 510(k) number K991462.

Who is the listed applicant for QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED?

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

What is the FDA product code for QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED?

The FDA product code for QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED is LYY.

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Other records listing Latexx Partners 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.

K011791POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLORK011792NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVESK992924QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATEDK992671QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVESK981767QTEXX POWDERFREE LATEX EXAMINATION GLOVESK981159PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES

View all 7 devices →

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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