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FDA 510(k)

Nitrile Patient Examination gloves, Powderfree, Blue color

K-Number: K143477 · 2016-04-14

Decision Date2016-04-14
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Patient Examination gloves, Powderfree, Blue color is the device name listed in this FDA 510(k) record. The listed applicant is Primus Gloves Pvt Limited. It received FDA 510(k) clearance on 2016-04-14 under 510(k) number K143477. 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 Nitrile Patient Examination gloves, Powderfree, Blue color?

Nitrile Patient Examination gloves, Powderfree, Blue color is a medical device that received FDA 510(k) clearance on 2016-04-14. The listed applicant is Primus Gloves Pvt Limited. The 510(k) number is K143477.

When did Nitrile Patient Examination gloves, Powderfree, Blue color receive FDA 510(k) clearance?

Nitrile Patient Examination gloves, Powderfree, Blue color received FDA 510(k) clearance on 2016-04-14, under 510(k) number K143477.

Who is the listed applicant for Nitrile Patient Examination gloves, Powderfree, Blue color?

The FDA 510(k) record lists Primus Gloves Pvt Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Patient Examination gloves, Powderfree, Blue color?

The FDA product code for Nitrile Patient Examination gloves, Powderfree, Blue color is LZA.

Other records listing Primus Gloves Pvt Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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