BOSMA OPPORTUNITY FLEX AND GOOD WORKS GLOVES
Received Sep 22, 2025
Report MW5176324 · MDR key 23121144
Device
Generic name
Fentanyl And Other Opioid Protection Glove
Manufacturer
Bosma Industries For The Blind, Inc.Lot number
AN250210949 SIZE M
Product problems
- Contamination
- Product Quality Problem
- Fail-Safe Problem
- Manufacturing, Packaging or Shipping Problem
- Material Split, Cut or Torn
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
SINCE (B)(6) 2024, RECURRING QUALITY ISSUES HAVE BEEN REPORTED WITH BOSMA GOOD WORKS GLOVES, POSING A POTENTIAL STAFF SAFETY RISK. STAFF NOTED THAT MANY GLOVES ARRIVE TORN, STICK TOGETHER, OR TEAR EASILY WHEN DONNED, COMPROMISING BARRIER PROTECTION. SOME GLOVES ARE ALSO RECEIVED PRE-SOILED. AFTER NOTIFYING THE COMPANY, THE HOSPITAL TRANSITIONED TO BOSMA OPPORTUNITY FLEX GLOVES; HOWEVER, THE SAME ISSUES PERSISTED, CONTINUING TO PLACE STAFF AT RISK OF EXPOSURE. AN250211252 SIZE SMALL AN250411331, AN250511406, AN250211282- SIZE S AN250411407 SIZE M, AN250210952 SIZE M, AN250210949 SIZE M, AN250210949 SIZE M, AN241110951 SIZE S, AN241110950 SIZE M. REFERENCE REPORT MW5176317, MW5176318, MW5176319, MW5176320, MW5176321, MW5176322, MW5176323, MW5176325, MW5176326.