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FDA 510(k)

MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES

K-Number: K040607 · 2004-04-22

ApplicantPt. Medisafe Technologies
Decision Date2004-04-22
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Medisafe Technologies. It received FDA 510(k) clearance on 2004-04-22 under 510(k) number K040607. 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 MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES?

MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2004-04-22. The listed applicant is Pt. Medisafe Technologies. The 510(k) number is K040607.

When did MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES receive FDA 510(k) clearance?

MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES received FDA 510(k) clearance on 2004-04-22, under 510(k) number K040607.

Who is the listed applicant for MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES?

The FDA 510(k) record lists Pt. Medisafe Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES?

The FDA product code for MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES is LZA.

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Related Devices (Code: LZA)

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.

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 CitrateCardinalhealthK260794NON-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 BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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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