FDA 510(k)

N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT

K-Number: K082125 · 2008-11-21

Decision Date2008-11-21

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT 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 2008-11-21 under 510(k) number K082125. 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 FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT?

N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT is a medical device that received FDA 510(k) clearance on 2008-11-21. The listed applicant is Best Glove, Inc.. The 510(k) number is K082125.

When did N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT receive FDA 510(k) clearance?

N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT received FDA 510(k) clearance on 2008-11-21, under 510(k) number K082125.

Who is the listed applicant for N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT?

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 FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT?

The FDA product code for N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT is LZA.

Related Clinical Trials

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Other records listing Best Glove, Inc. as applicant

K082428N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE

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.