Medical examination gloves recalled for skin irritation and disintegration
SVS LLC is recalling 155,540 boxes of non-sterile nitrile examination gloves due to reported skin irritation, glove disintegration with certain cleaning solutions, and size mislabeling. Gloves were distributed nationwide across eight U.S. states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with reported skin irritation and functional defects (disintegration). While injury has been reported, it is not serious enough to qualify for Severe (which requires hospitalization or significant injury reports), but actual injury complaints elevate this above Moderate severity.
Plain-English summary
SVS LLC is recalling approximately 155,540 boxes of non-sterile, single-use, powder-free nitrile examination gloves (available in sizes XS through XL). The gloves are intended for medical professionals to wear during patient examinations to prevent contamination between patient and examiner.
The recall was initiated following consumer complaints of skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeling of products where the outer box indicates one size but the inner box indicates a different size.
The recalled gloves were distributed nationwide in Michigan, Nebraska, Florida, Georgia, Pennsylvania, Arkansas, Colorado, and New York. Additional details including specific lot numbers and item codes are available from the FDA.
The recalled product
- 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…
- Manufacturer
- SVS LLC
- Affected units
- 155,540
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- AEAM1112
- AEAN0318
Distribution
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