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FDA 510(k)

Sterile Nitrile Surgical Gloves, Powder-free

K-Number: K170515 · 2017-06-09

ApplicantPrimus Gloves Pvt Limited
Decision Date2017-06-09
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Nitrile Surgical Gloves, Powder-free is a medical device manufactured by Primus Gloves Pvt Limited. It received FDA 510(k) clearance on 2017-06-09 under approval 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. It is manufactured by Primus Gloves Pvt Limited. The 510(k) number is K170515.

When was Sterile Nitrile Surgical Gloves, Powder-free approved by the FDA?

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

What company makes Sterile Nitrile Surgical Gloves, Powder-free?

Sterile Nitrile Surgical Gloves, Powder-free is manufactured by Primus Gloves Pvt Limited.

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.

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Other Devices by Primus Gloves Pvt Limited

K143477Nitrile Patient Examination gloves, Powderfree, Blue color K170612STERILE VINYL EXAMINATION GLOVES, Powder Free

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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