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FDA 510(k)

Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use

K-Number: K192988 · 2020-04-01

Decision Date2020-04-01
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2020-04-01 under approval number K192988. 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 Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use?

Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use is a medical device that received FDA 510(k) clearance on 2020-04-01. It is manufactured by Medline Industries, Inc.. The 510(k) number is K192988.

When was Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use approved by the FDA?

Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use received FDA 510(k) clearance on 2020-04-01, under approval number K192988.

What company makes Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use?

Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use is manufactured by Medline Industries, Inc..

What is the FDA product code for Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use?

The FDA product code for Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use 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.