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FDA 510(k)

BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES

K-Number: K081972 · 2008-12-11

ApplicantNitritex (M) Sdn. Bhd.
Decision Date2008-12-11
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Nitritex (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2008-12-11 under 510(k) number K081972. 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 BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES?

BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2008-12-11. The listed applicant is Nitritex (M) Sdn. Bhd.. The 510(k) number is K081972.

When did BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES receive FDA 510(k) clearance?

BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES received FDA 510(k) clearance on 2008-12-11, under 510(k) number K081972.

Who is the listed applicant for BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES?

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

What is the FDA product code for BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES?

The FDA product code for BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE 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 Nitritex (M) Sdn. Bhd. as applicant

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.

K081970BIOCLEAN CHEMO SHIELDK081971BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES

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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