FDA 510(k)

POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR

K-Number: K011791 · 2001-08-01

Decision Date2001-08-01

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR 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 2001-08-01 under 510(k) number K011791. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR?

POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR is a medical device that received FDA 510(k) clearance on 2001-08-01. The listed applicant is Latexx Partners Bhd.. The 510(k) number is K011791.

When did POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR receive FDA 510(k) clearance?

POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR received FDA 510(k) clearance on 2001-08-01, under 510(k) number K011791.

Who is the listed applicant for POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR?

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 POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR?

The FDA product code for POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR is LZA.

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Other records listing Latexx Partners Bhd. as applicant

K011792NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES K992924QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED K992671QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES K991462QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED K981767QTEXX POWDERFREE LATEX EXAMINATION GLOVES K981159PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES

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Related Devices (Code: LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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.