FDA 510(k)

MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)

K-Number: K001619 · 2000-07-26

Decision Date2000-07-26

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) is the device name listed in this FDA 510(k) record. The listed applicant is Multisafe Sdn. Bhd.. It received FDA 510(k) clearance on 2000-07-26 under 510(k) number K001619. 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 MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)?

MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) is a medical device that received FDA 510(k) clearance on 2000-07-26. The listed applicant is Multisafe Sdn. Bhd.. The 510(k) number is K001619.

When did MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) receive FDA 510(k) clearance?

MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) received FDA 510(k) clearance on 2000-07-26, under 510(k) number K001619.

Who is the listed applicant for MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)?

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

What is the FDA product code for MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)?

The FDA product code for MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) is LZA.

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Other records listing Multisafe Sdn. Bhd. as applicant

K161085Nitrile Patient Examination Powder Free Glove, Textured, Black K062526BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE K062527BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE K011293POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES K001497MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)K000999MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

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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

View on FDA Database →

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