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FDA 510(k)

FlexGard Cut-Resistant Glove Liners

K-Number: K190782 · 2019-06-27

Decision Date2019-06-27
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FlexGard Cut-Resistant Glove Liners is a medical device manufactured by Ldi Corporation. It received FDA 510(k) clearance on 2019-06-27 under approval number K190782. 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 FlexGard Cut-Resistant Glove Liners?

FlexGard Cut-Resistant Glove Liners is a medical device that received FDA 510(k) clearance on 2019-06-27. It is manufactured by Ldi Corporation. The 510(k) number is K190782.

When was FlexGard Cut-Resistant Glove Liners approved by the FDA?

FlexGard Cut-Resistant Glove Liners received FDA 510(k) clearance on 2019-06-27, under approval number K190782.

What company makes FlexGard Cut-Resistant Glove Liners?

FlexGard Cut-Resistant Glove Liners is manufactured by Ldi Corporation.

What is the FDA product code for FlexGard Cut-Resistant Glove Liners?

The FDA product code for FlexGard Cut-Resistant Glove Liners is KGO.

Related Devices (Code: KGO)

Official Source

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