FDA 510(k)

NITRILE EXAMINATION GLOVES-PRE POWDERED

K-Number: K970216 · 1997-09-26

Decision Date1997-09-26

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NITRILE EXAMINATION GLOVES-PRE POWDERED is the device name listed in this FDA 510(k) record. The listed applicant is Influx Pacific Sdn. Bhd.. It received FDA 510(k) clearance on 1997-09-26 under 510(k) number K970216. 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 NITRILE EXAMINATION GLOVES-PRE POWDERED?

NITRILE EXAMINATION GLOVES-PRE POWDERED is a medical device that received FDA 510(k) clearance on 1997-09-26. The listed applicant is Influx Pacific Sdn. Bhd.. The 510(k) number is K970216.

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

NITRILE EXAMINATION GLOVES-PRE POWDERED received FDA 510(k) clearance on 1997-09-26, under 510(k) number K970216.

Who is the listed applicant for NITRILE EXAMINATION GLOVES-PRE POWDERED?

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

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

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

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Other records listing Influx Pacific Sdn. Bhd. as applicant

K980511NITRILE EXAMINATION GLOVES - POWDER FREE K930407POWDER-FREE LATEX EXAMINATION GLOVES K910895SURGICAL GLOVES K891668PATIENT EXAMINATION GLOVES (LATEX)

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.