Device product
MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.
Z-0051-2021
Product summary
- Event
- Event 86352
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1312 Cases
- Official record key
device-enforcement:Z-0051-2021
Official wording
Reason: Examination gloves were shipped inadvertently, without to verify barrier integrity.
Code information: Lot: 2003LG, Batch: 20035314LG
Distribution pattern: U.S. Nationwide distribution including in the states of IL, OK, WI, PA, TX, OH, MI, IN, VA, AR, KS, MO, NV, OR, FL, QC, NJ, NE, KY, AL, TN, LA, NY, SC, MS, MD, CA, GA, SD.
Derived failure modes
-
Unknown
Examination gloves were shipped inadvertently, without to verify barrier integrity.