Z-0051-2021Class II

MICROFLEX Diamond Grip Examination Gloves, MF-300 -

Name: Z-0051-2021 MICROFLEX Diamond Grip Examination Gloves, MF-300 -
Creator: Ansell Healthcare Products LLC
Published: 2020-08-19
License: https://open.fda.gov/license/

Ansell Healthcare Products LLC / initiated 2020-08-19 / Terminated

FDA source

Ansell Healthcare Products LLC began a recall of MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is... on 2020-08-19. FDA classified it as Class II and gives the reason as "Examination gloves were shipped inadvertently, without to verify barrier integrity". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0051-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-19
Posted: 2020-10-02
Terminated: 2021-11-03
Recalling firm: Ansell Healthcare Products LLC
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.
Product code: LYY Latex Patient Examination Glove
Reason for recall: Examination gloves were shipped inadvertently, without to verify barrier integrity.
FDA root cause: Under Investigation by firm
Action: On 08/19/2020, recall notices were emailed to customers who were asked to do the following: If you believe you may have received affected product, please visit: http://www.novasyte.com/ansell/capa-206-2020 to complete the necessary acknowledgement form. Upon completion of the acknowledgement form, Ansell will partner with you to arrange for a return of the product, provide a credit, and offer you the option of a reship. For any assistance regarding the acknowledgement form, please contact Novasyte at 855-863-7288 or [email protected] Novasyte emailed E-Mail/ Letter for Distributors to Send End-User Customers, Dated 08/18/20, to distributors informing them to send this letter to the end users. End users were asked to return affected products to distributors. On 08/21/2020, the firm followed up with customers via phone.
Quantity in commerce: 1312 Cases
Distribution: 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.
Product codes and lots: Lot: 2003LG, Batch: 20035314LG

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0051-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0051-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-02

Product code LYY

K974424Class IComfort Rubber Gloves Industries Sdn BhdComfort Rubber Gloves Industries Sdn. Bhd. / cleared 1998-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)