FDA 510(k)

NITRILE BLUE POWDERED EXAMINATION GLOVES

K-Number: K052955 · 2006-01-19

Decision Date2006-01-19

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NITRILE BLUE POWDERED EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Great Glove Sdn Bhd. It received FDA 510(k) clearance on 2006-01-19 under 510(k) number K052955. 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 BLUE POWDERED EXAMINATION GLOVES?

NITRILE BLUE POWDERED EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2006-01-19. The listed applicant is Great Glove Sdn Bhd. The 510(k) number is K052955.

When did NITRILE BLUE POWDERED EXAMINATION GLOVES receive FDA 510(k) clearance?

NITRILE BLUE POWDERED EXAMINATION GLOVES received FDA 510(k) clearance on 2006-01-19, under 510(k) number K052955.

Who is the listed applicant for NITRILE BLUE POWDERED EXAMINATION GLOVES?

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

What is the FDA product code for NITRILE BLUE POWDERED EXAMINATION GLOVES?

The FDA product code for NITRILE BLUE POWDERED EXAMINATION GLOVES is LZA.

Related Clinical Trials

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.

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Other records listing Great Glove Sdn Bhd as applicant

K052956NITRILE BLUE POWDER FREE EXAMINATION GLOVE K020363GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)K993386LATEX EXAMINATION POWDERED GLOVES

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.