MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,SENSICR PI ORTHO LT,LF,PF,7.0

Catalog Number	MSG9970
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "msg9970 gloves are ripping when donning.".
Additional Manufacturer Narrative
The customer stated the surgical gloves were "ripping while putting on the gloves," and the glove was not used for treatment due to it ripping prior to treatment.The account provided one already ripped glove and one unopened glove wallet; the wallet was opened and the two gloves inside were donned and evaluated, with no tearing present, and the two gloves were also measured for thickness, palm width, and overall length.One glove failed to meet the required product specifications, measuring 0.43 mm at the palm and 0.34 mm at the cuff; although the returned sample did not tear during testing, the thickness of the glove was not within the allotted specifications, which could contribute to tearing, and medline confirmed the reported issue.Further investigation reveals that the root cause is attributed to a vendor product issue related to the component manufacturing process as the gloves did not meet product specifications; there were no reports of 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,SENSICR PI ORTHO LT,LF,PF,7.0
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913898
• Report Number: 1417592-2026-51844
• Device Sequence Number: 17491115
• Product Code: KGO
• UDI-Device Identifier: 10193489029857
• UDI-Public: 10193489029857
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142941
• 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): 09/25/2026

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: MSG9970
• Device Lot Number: 2109969270
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/13/2026
• 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: 12/17/2025
• Initial Report FDA Received Date: 09/28/2026
• 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