FDA 510(k)

NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE

K-Number: K000223 · 2000-04-14

ApplicantPhoenix Medical Technology, Inc.

Decision Date2000-04-14

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Medical Technology, Inc.. It received FDA 510(k) clearance on 2000-04-14 under 510(k) number K000223. 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 NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE?

NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE is a medical device that received FDA 510(k) clearance on 2000-04-14. The listed applicant is Phoenix Medical Technology, Inc.. The 510(k) number is K000223.

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

NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE received FDA 510(k) clearance on 2000-04-14, under 510(k) number K000223.

Who is the listed applicant for NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE?

The FDA 510(k) record lists Phoenix Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE?

The FDA product code for NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE is LZA.

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Other records listing Phoenix Medical Technology, Inc. as applicant

K945045PATIENT EXAINATION GLOVES K905031PATIENT EXAMINATION GLOVES K900454MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES K900453MODIFIED SINGLE USE LATEX EXAMINATION GLOVES K890917PHOENIX DRAPES WITH MICROBAN K892976SINGLE USE VINYL EXAM GLOVES - COLOR CODED

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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.