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FDA 510(k)

Sterile Nitrile Surgical Gloves, Powder-free

K-Number: K170515 · 2017-06-09

Decision Date2017-06-09
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Nitrile Surgical Gloves, Powder-free 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 2017-06-09 under 510(k) number K170515. 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 Sterile Nitrile Surgical Gloves, Powder-free?

Sterile Nitrile Surgical Gloves, Powder-free is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is Primus Gloves Pvt Limited. The 510(k) number is K170515.

When did Sterile Nitrile Surgical Gloves, Powder-free receive FDA 510(k) clearance?

Sterile Nitrile Surgical Gloves, Powder-free received FDA 510(k) clearance on 2017-06-09, under 510(k) number K170515.

Who is the listed applicant for Sterile Nitrile Surgical Gloves, Powder-free?

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 Sterile Nitrile Surgical Gloves, Powder-free?

The FDA product code for Sterile Nitrile Surgical Gloves, Powder-free is KGO.

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: KGO)

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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