FDA 510(k)

NITRILE POWDER-FREE UNISEAL GLOVES

K-Number: K982218 · 1998-11-30

ApplicantAmerican Healthcare Products (M) Sdn Bhd

Decision Date1998-11-30

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NITRILE POWDER-FREE UNISEAL GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is American Healthcare Products (M) Sdn Bhd. It received FDA 510(k) clearance on 1998-11-30 under 510(k) number K982218. 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 POWDER-FREE UNISEAL GLOVES?

NITRILE POWDER-FREE UNISEAL GLOVES is a medical device that received FDA 510(k) clearance on 1998-11-30. The listed applicant is American Healthcare Products (M) Sdn Bhd. The 510(k) number is K982218.

When did NITRILE POWDER-FREE UNISEAL GLOVES receive FDA 510(k) clearance?

NITRILE POWDER-FREE UNISEAL GLOVES received FDA 510(k) clearance on 1998-11-30, under 510(k) number K982218.

Who is the listed applicant for NITRILE POWDER-FREE UNISEAL GLOVES?

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

What is the FDA product code for NITRILE POWDER-FREE UNISEAL GLOVES?

The FDA product code for NITRILE POWDER-FREE UNISEAL GLOVES is LZA.

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Other records listing American Healthcare Products (M) Sdn Bhd as applicant

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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.