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FDA 510(k)

SUR-G GLOV AND MAXITEX

K-Number: K102119 · 2010-08-27

ApplicantTerang Nusa Sdn Bhd
Decision Date2010-08-27
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUR-G GLOV AND MAXITEX 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 2010-08-27 under 510(k) number K102119. 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 SUR-G GLOV AND MAXITEX?

SUR-G GLOV AND MAXITEX is a medical device that received FDA 510(k) clearance on 2010-08-27. The listed applicant is Terang Nusa Sdn Bhd. The 510(k) number is K102119.

When did SUR-G GLOV AND MAXITEX receive FDA 510(k) clearance?

SUR-G GLOV AND MAXITEX received FDA 510(k) clearance on 2010-08-27, under 510(k) number K102119.

Who is the listed applicant for SUR-G GLOV AND MAXITEX?

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 SUR-G GLOV AND MAXITEX?

The FDA product code for SUR-G GLOV AND MAXITEX 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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