FDA 510(k)

NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE

K-Number: K031580 · 2003-07-25

Decision Date2003-07-25

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Green Prospect Sdn Bhd. It received FDA 510(k) clearance on 2003-07-25 under 510(k) number K031580. 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 NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE?

NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 2003-07-25. The listed applicant is Green Prospect Sdn Bhd. The 510(k) number is K031580.

When did NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE receive FDA 510(k) clearance?

NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE received FDA 510(k) clearance on 2003-07-25, under 510(k) number K031580.

Who is the listed applicant for NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE?

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

What is the FDA product code for NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE?

The FDA product code for NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE is LZA.

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Other records listing Green Prospect Sdn Bhd as applicant

K031581NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE COLOR, WITH PROTEIN LABELING, CONTAINS 50 MICROG

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.