MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP DERMASSURE; GLOVE, SURG, DERMASSURE GRN, LF, PF, 6.5

Catalog Number	MSG6565
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Temperature Problem (3022); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer on january 23rd, a technician experienced "a flare up of her contact dermatitis after using a sample of new gloves" (dermassure green gloves).The customer stated that earlier in january, the technician developed irritation, redness, and swelling of the hands following use of seniscare gloves, which required a physician visit and treatment with oral medication and a topical cream.After discontinuing use of sensicare gloves, the technician waited approximately one and a half weeks before using the dermassure green gloves, during which time symptoms were managed with medication.However, the customer reported the technician experienced a recurrence of contact dermatitis after using the sample box of the new gloves (dermassure green gloves).No additional information is available at this time.A sample has been requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer on january 23rd, a technician experienced "a flare up of her contact dermatitis after using a sample of new gloves (dermassure green gloves)".
Additional Manufacturer Narrative
Updated: b4.Date of this report.D4.Lot # and expiration date.E2.Health professional.E3.Occupation.E4.Initial reporter also sent report to fda.H4.Device manufacture date.Replaced h6:adverse event problem health effect - clinical code (e).Added h6.Adverse event problem medical device problem code (a).

• Brand Name: DERMASSURE
• Common Device Name: GLOVE, SURG, DERMASSURE GRN, LF, PF, 6.5
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24433285
• Report Number: 1417592-2026-00145
• Device Sequence Number: 13322971
• Product Code: KGO
• UDI-Device Identifier: 10888277346550
• UDI-Public: 10888277346550
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MSG6565
• Device Lot Number: 25DAO334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female