Recall Z-0051-2021— Ansell Healthcare Products LLC
Class II · Terminated
Class II FDA medical device recall by Ansell Healthcare Products LLC, initiated 2020-08-19, terminated 2021-11-03. It names one FDA 510(k) clearance: K974424. 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.. Reason: Examination gloves were shipped inadvertently, without to verify barrier integrity..
- Recalling firm
- Ansell Healthcare Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-19
- Terminated
- 2021-11-03
- Firm location
- Reno, NV, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Examination gloves were shipped inadvertently, without to verify barrier integrity.
Data sourced from openFDA. This site is unofficial and independent of the FDA.