FDA 510(k)

PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES

K-Number: K981159 · 1998-06-01

Decision Date1998-06-01

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES 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 1998-06-01 under 510(k) number K981159. 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 PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES?

PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1998-06-01. The listed applicant is Latexx Partners Bhd.. The 510(k) number is K981159.

When did PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES receive FDA 510(k) clearance?

PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES received FDA 510(k) clearance on 1998-06-01, under 510(k) number K981159.

Who is the listed applicant for PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES?

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 PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES?

The FDA product code for PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES is LZA.

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Other records listing Latexx Partners Bhd. as applicant

K011791POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR 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

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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.