Z-2320-2024Class II

Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners...

Name: Z-2320-2024 Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners...
Creator: Svs Llc
Published: 2024-05-13
License: https://open.fda.gov/license/

SVS LLC / initiated 2024-05-13 / Open, Classified / root cause: labeling and UDI

FDA source

SVS LLC began a recall of Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an... on 2024-05-13. FDA classified it as Class II and gives the reason as "Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2320-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-13
Posted: 2024-07-09
Recalling firm: SVS LLC
Product: Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.
Product code: LZC Medical Glove, Specialty
Reason for recall: Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another size).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Consignees were notified via email on 05/13/2024. The consignees are instructed to discontinue using PremierPro PlusTM D506X series exam gloves; Notify end-users of this voluntary recall notification and discontinue use of the products within your healthcare facilities; Remove these products from areas where they may be available including all points of care, supply part locations, and central supply warehouses; Return the products within Table A above to the firm at the firm's expense. All returns of the above-listed products will be replaced by S2S Global with internationally-sourced PremierProTM 506x gloves unless the consignee indicates a different preference; Continue reporting any and all issues that may arise with the use of domestically-sourced PremierPro PlusTM D506X series exam gloves to S2S Global; and " Return the completed Medical Device Recall Return Response Acknowledgement and Receipt Form located in Appendix A below to S2S Global.
Quantity in commerce: 155,540 inner boxes
Distribution: US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.
Product codes and lots: Item Numbers: size XS - D5061/lot number: AEAM1105/UDI: 00811220035433; size S - D5062/lot number: AEAM1103,AEAM1104,AEAM1105,AEAM1106,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0310,AEAN0311,AEAN0312,AEAN0316,AEAN0317,AEAN0318/ UDI: 00811220035440; size M - D5063/lot number: AEAM1104,AEAM1105,AEAM1112,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0311,AEAN0312,AEAN0316,AEAN0317,AEAN0318,AEAN0319,AEAN0320,AEAN0206/UDI: 00811220035457; size L - D5064/lot number: AEAM1103,AEAM1104,AEAM1106,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0310,AEAN0311,AEAN0312,AEAN0317,AEAN0318,AEAN0319,AEAN0320/UDI: 00811220035464; and size XL D5065/lot number: AEAN0204,AEAN0205,AEAN0206,AEAN0308,AEAN0310,AEAN0311/UDI: 00811220035471

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2320-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2320-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-09

Product code LZC

K220825Class ISapphire Pro Powder-Free Royal Blue Nitrile Exam GlovesAmerican Nitrile Operations, LLC / cleared 2022-07-08

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)