FDA 510(k)

N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE

K-Number: K082428 · 2009-02-10

Decision Date2009-02-10

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Best Glove, Inc.. It received FDA 510(k) clearance on 2009-02-10 under 510(k) number K082428. 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 N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE?

N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE is a medical device that received FDA 510(k) clearance on 2009-02-10. The listed applicant is Best Glove, Inc.. The 510(k) number is K082428.

When did N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE receive FDA 510(k) clearance?

N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE received FDA 510(k) clearance on 2009-02-10, under 510(k) number K082428.

Who is the listed applicant for N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE?

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

What is the FDA product code for N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE?

The FDA product code for N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE is LZA.

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Other records listing Best Glove, 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.