FDA 510(k)

POWDERED BLUE NITRILE EXAMINATION GLOVES

K-Number: K011924 · 2001-07-10

Decision Date2001-07-10

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDERED BLUE NITRILE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Seltom Pacific Sdn. Bhd.. It received FDA 510(k) clearance on 2001-07-10 under 510(k) number K011924. 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 POWDERED BLUE NITRILE EXAMINATION GLOVES?

POWDERED BLUE NITRILE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2001-07-10. The listed applicant is Seltom Pacific Sdn. Bhd.. The 510(k) number is K011924.

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

POWDERED BLUE NITRILE EXAMINATION GLOVES received FDA 510(k) clearance on 2001-07-10, under 510(k) number K011924.

Who is the listed applicant for POWDERED BLUE NITRILE EXAMINATION GLOVES?

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

What is the FDA product code for POWDERED BLUE NITRILE EXAMINATION GLOVES?

The FDA product code for POWDERED BLUE NITRILE EXAMINATION GLOVES is LZA.

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Other records listing Seltom Pacific Sdn. Bhd. as applicant

K011922POWDERED LATEX EXAMINATION GLOVES K003934POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)K991777LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)K991778LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)K991776NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)K991779NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)

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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

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