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FDA 510(k)

BLUE NITRILE EXAMINATION GLOVES - POWDER FREE

K-Number: K994064 · 2000-01-28

ApplicantGlove Source, Inc.
Decision Date2000-01-28
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BLUE NITRILE EXAMINATION GLOVES - POWDER FREE is the device name listed in this FDA 510(k) record. The listed applicant is Glove Source, Inc.. It received FDA 510(k) clearance on 2000-01-28 under 510(k) number K994064. 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 BLUE NITRILE EXAMINATION GLOVES - POWDER FREE?

BLUE NITRILE EXAMINATION GLOVES - POWDER FREE is a medical device that received FDA 510(k) clearance on 2000-01-28. The listed applicant is Glove Source, Inc.. The 510(k) number is K994064.

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

BLUE NITRILE EXAMINATION GLOVES - POWDER FREE received FDA 510(k) clearance on 2000-01-28, under 510(k) number K994064.

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

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

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

The FDA product code for BLUE NITRILE EXAMINATION GLOVES - POWDER FREE 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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