FDA 510(k)

ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET

K-Number: K120110 · 2012-10-04

ApplicantProfit Point Manufacturing Sdn Bhd

Decision Date2012-10-04

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET is the device name listed in this FDA 510(k) record. The listed applicant is Profit Point Manufacturing Sdn Bhd. It received FDA 510(k) clearance on 2012-10-04 under 510(k) number K120110. 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 ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET?

ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET is a medical device that received FDA 510(k) clearance on 2012-10-04. The listed applicant is Profit Point Manufacturing Sdn Bhd. The 510(k) number is K120110.

When did ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET receive FDA 510(k) clearance?

ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET received FDA 510(k) clearance on 2012-10-04, under 510(k) number K120110.

Who is the listed applicant for ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET?

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

What is the FDA product code for ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET?

The FDA product code for ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET is LZA.

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Other records listing Profit Point Manufacturing Sdn Bhd as applicant

K101760ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES

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.