Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K192988 · 2020-04-01

ApplicantMedline Industries, Inc.
Decision Date2020-04-01
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2020-04-01 under 510(k) 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. The listed applicant is Medline Industries, Inc.. The 510(k) number is K192988.

When did Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use receive FDA 510(k) clearance?

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

Who is the listed applicant for Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07613892Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure AdhesivesCOMPLETEDNCT07734220Evaluation of Two Heel Protection Devices to Assess Off-loading Via Pressure Mapping.COMPLETEDNCT05989750Air-polishing With Erythritol During Orthodontic TretamentRECRUITINGNCT06420323NovoX®Cup as Primary Dressing After Breast ReductionACTIVE_NOT_RECRUITING

Other records listing Medline Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)K222665Medline UNITE® Ankle Fusion Plating SystemK213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeK212911Konig Mogen ClampK220565Hudson RCI Triflo II Incentive Deep Breathing Exerciser

View all 74 devices →

Related Devices (Code: KGO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

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.

↑