FDA 510(k)

POWDER-FREE NITRILE GLOVES, BLACK

K-Number: K100369 · 2010-05-20

Decision Date2010-05-20

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER-FREE NITRILE GLOVES, BLACK is the device name listed in this FDA 510(k) record. The listed applicant is Hl Rubber Industries Sdn Bhd. It received FDA 510(k) clearance on 2010-05-20 under 510(k) number K100369. 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 POWDER-FREE NITRILE GLOVES, BLACK?

POWDER-FREE NITRILE GLOVES, BLACK is a medical device that received FDA 510(k) clearance on 2010-05-20. The listed applicant is Hl Rubber Industries Sdn Bhd. The 510(k) number is K100369.

When did POWDER-FREE NITRILE GLOVES, BLACK receive FDA 510(k) clearance?

POWDER-FREE NITRILE GLOVES, BLACK received FDA 510(k) clearance on 2010-05-20, under 510(k) number K100369.

Who is the listed applicant for POWDER-FREE NITRILE GLOVES, BLACK?

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

What is the FDA product code for POWDER-FREE NITRILE GLOVES, BLACK?

The FDA product code for POWDER-FREE NITRILE GLOVES, BLACK is LZA.

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Other records listing Hl Rubber Industries Sdn Bhd as applicant

K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs K130038POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE K063522POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)K063524POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)

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.