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

FDA 510(k) K192988 · Medline Industries, Inc.

Substantially Equivalent

510(k) numberK192988

Submission

Device name
Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use
Applicant
Medline Industries, Inc.
Northfield, IL, US
Received
October 25, 2019
Decision date
April 1, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KGO – Surgeon'S Gloves
Device class
Class I (low risk)
Regulation
21 CFR 878.4460
Specialty
General, Plastic Surgery

A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

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K253060Sterile Latex Powder Free Surgical GlovesKGO · Traditional Protect Gloves Company Limited05/22/2026SE
K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With…KGO · Abbreviated Harps Europe Manufacturing GmbH08/19/2025SE
K240790Polyisoprene Surgical glovesKGO · Traditional Suzhou Colour-Way New Material Co., Ltd.08/23/2024SE
K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with…KGO · Traditional Wrp Asia Pacific Sdn. Bhd.03/28/2024SE
K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsKGO · Traditional Grand Work Plastic Products Co., Ltd.12/20/2023SE
K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid…KGO · Traditional Ansell Healthcare10/20/2023SE
K231973PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical GloveKGO · Traditional Ineo Tech Sdn Bhd09/29/2023SE
K231446Single-Use Latex Sterile Surgical Gloves (SG100)KGO · Traditional Fitone Latex Products Co., Ltd. Guangdong09/22/2023SE
K230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with…KGO · Traditional Wrp Asia Pacific Sdn. Bhd.08/31/2023SE

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Questions and answers

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

Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use (K192988) received a 510(k) decision of Substantially Equivalent on April 1, 2020, 159 days after the submission was received.

What is the product code of K192988?

The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.