MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,SENSICARE PI,LF,PF,7.5

Catalog Number	MSG9075Z
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the gloves are ripping once the surgeon puts them on.".
Additional Manufacturer Narrative
The customer stated that the gloves are ripping once the surgeon puts them on.Medline received 2 bx for review and was unable to identify any issues with the returned samples; when donning the gloves with both 4 fingers and 1 fingers for 32 ea, no ripping/tearing could be replicated.The complaint issue and that the product failed to meet specifications were unable to be confirmed based off the samples provided; cause was not confirmed with received sample.Trending did not indicate a trend of tearing when donning or similar occurring in the field, the lot inspection was completed with passing results, and no need for further action was indicated at this time.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: GLOVE,SURG,SENSICARE PI,LF,PF,7.5
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50566973
• Report Number: 1417592-2026-30581
• Device Sequence Number: 13385809
• Product Code: KGO
• UDI-Device Identifier: 10888277347908
• UDI-Public: 10888277347908
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MSG9075Z
• Device Lot Number: 4097724175-3
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown