FDA 510(k)

NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE

K-Number: K982131 · 1998-10-29

Decision Date1998-10-29

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Edmont Industrial, Inc.. It received FDA 510(k) clearance on 1998-10-29 under 510(k) number K982131. 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 NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE?

NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1998-10-29. The listed applicant is Ansell Edmont Industrial, Inc.. The 510(k) number is K982131.

When did NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE receive FDA 510(k) clearance?

NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE received FDA 510(k) clearance on 1998-10-29, under 510(k) number K982131.

Who is the listed applicant for NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE?

The FDA 510(k) record lists Ansell Edmont Industrial, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE?

The FDA product code for NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE is LZA.

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Other records listing Ansell Edmont Industrial, Inc. as applicant

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Related Devices (Code: LZA)

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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.