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FDA 510(k)

NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)

K-Number: K051777 · 2005-08-12

ApplicantHartalega Sdn Bhd
Decision Date2005-08-12
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega Sdn Bhd. It received FDA 510(k) clearance on 2005-08-12 under 510(k) number K051777. 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 POWDER FREE EXAMINATION GLOVES (BLUE)?

NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) is a medical device that received FDA 510(k) clearance on 2005-08-12. The listed applicant is Hartalega Sdn Bhd. The 510(k) number is K051777.

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

NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) received FDA 510(k) clearance on 2005-08-12, under 510(k) number K051777.

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

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

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

The FDA product code for NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) 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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