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FDA 510(k)

Sterile Latex Powder-Free Surgical Gloves

K-Number: K191898 · 2019-12-18

ApplicantModern Healthcare Corp.
Decision Date2019-12-18
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Latex Powder-Free Surgical Gloves is a medical device manufactured by Modern Healthcare Corp.. It received FDA 510(k) clearance on 2019-12-18 under approval number K191898. 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 Latex Powder-Free Surgical Gloves?

Sterile Latex Powder-Free Surgical Gloves is a medical device that received FDA 510(k) clearance on 2019-12-18. It is manufactured by Modern Healthcare Corp.. The 510(k) number is K191898.

When was Sterile Latex Powder-Free Surgical Gloves approved by the FDA?

Sterile Latex Powder-Free Surgical Gloves received FDA 510(k) clearance on 2019-12-18, under approval number K191898.

What company makes Sterile Latex Powder-Free Surgical Gloves?

Sterile Latex Powder-Free Surgical Gloves is manufactured by Modern Healthcare Corp..

What is the FDA product code for Sterile Latex Powder-Free Surgical Gloves?

The FDA product code for Sterile Latex Powder-Free Surgical Gloves is KGO.

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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.

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