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FDA 510(k)

NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN

K-Number: K000178 · 2000-05-23

ApplicantTerang Nusa Sdn Bhd
Decision Date2000-05-23
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN is the device name listed in this FDA 510(k) record. The listed applicant is Terang Nusa Sdn Bhd. It received FDA 510(k) clearance on 2000-05-23 under 510(k) number K000178. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN?

NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN is a medical device that received FDA 510(k) clearance on 2000-05-23. The listed applicant is Terang Nusa Sdn Bhd. The 510(k) number is K000178.

When did NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN receive FDA 510(k) clearance?

NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN received FDA 510(k) clearance on 2000-05-23, under 510(k) number K000178.

Who is the listed applicant for NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN?

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

What is the FDA product code for NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN?

The FDA product code for NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN is KGO.

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Related Devices (Code: KGO)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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