FDA 510(k)

MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)

K-Number: K001497 · 2000-07-26

Decision Date2000-07-26

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MULTISAFE-POWDERED 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 K001497. 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-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)?

MULTISAFE-POWDERED 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 K001497.

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

MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE) received FDA 510(k) clearance on 2000-07-26, under 510(k) number K001497.

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

The FDA product code for MULTISAFE-POWDERED 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 K001619MULTISAFE POWDER FREE 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.