MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,SIGNATURE LTX,ESS,LTX,PF,6

Catalog Number	MSG5965
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Other
Event or Problem Description
It was reported that "the gloves below have been very sticky lately and have been ripping easily." it was also reported that "one of their techs had to put on 3 pairs because they were all ripping" and "the stickiness feeling is when the glove is on and you rub fingers together.".
Additional Manufacturer Narrative
The customer reported that the gloves have been very sticky lately and have been ripping easily, and one of their techs had to put on 3 pairs because they were all ripping.Inspection reports were reviewed, the lot passed inspection for all physical properties per astm standards, a historical complaint query was performed, and samples were later received and evaluated, including assessment for tearing and surface tackiness.Medline was unable to replicate tearing and did not find the gloves to be tacky/sticky; no defects were observed and the complaint is determined to be unconfirmed.A root cause could not be identified, as no defect was observed during evaluation, and medline is unable to confirm the complaint issue or that the product failed to meet specifications; there was no reported death or serious injury associated with this event.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,SIGNATURE LTX,ESS,LTX,PF,6
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50932632
• Report Number: 1417592-2026-53114
• Device Sequence Number: 15834117
• Product Code: KGO
• UDI-Device Identifier: 30888277629725
• UDI-Public: 30888277629725
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183536
• 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): 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: MSG5965
• Device Lot Number: 1033295665-1
• Was Device Available for Evaluation?: Yes
• 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: 05/16/2023
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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