Disposable Medical Gloves (SVS) – Skin Irritation Risk (2024)
Medical gloves may cause skin irritation or disintegrate with certain cleaning solutions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
SVS LLC
Lot Codes / Batch Numbers
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
Products Sold
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
SVS LLC is recalling Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of due to Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026