FDA 510(k)

POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)

K-Number: K980280 · 1998-03-13

Decision Date1998-03-13

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) is the device name listed in this FDA 510(k) record. The listed applicant is Besglove Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 1998-03-13 under 510(k) number K980280. 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 NITRILE EXAMINATION GLOVES (BLUE COLOUR)?

POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) is a medical device that received FDA 510(k) clearance on 1998-03-13. The listed applicant is Besglove Medicare Sdn. Bhd.. The 510(k) number is K980280.

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

POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) received FDA 510(k) clearance on 1998-03-13, under 510(k) number K980280.

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

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

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

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

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Other records listing Besglove Medicare Sdn. Bhd. as applicant

K994082POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)K993500POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS)K993502POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)K993495POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS)K981877NITRILE POWDERFREE EXAMINATION GLOVES K982286POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)

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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.