MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD SKYBREEZE POWDER-FREE NITRILE EXAM GLOVES M

Model Number	47375
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Local Reaction (2035)
Type of Reportable Event	Serious Injury
Event or Problem Description
The nurse experienced intense itching and redness affecting the fingers, palms, backs of the hands, and wrists.The reaction occurred during the first use, within the first two hours of wear.No medical treatment was required, and the symptoms resolved without intervention.The nurse has had similar reaction in the past with plastic gloves; however, never with other brands of nitrile gloves.
Additional Manufacturer Narrative
Incident 2 of 2 a review of the manufacturing process for skybreeze nitrile gloves confirms that shandong intco medical products co., ltd.Introduces these gloves in accordance with an approved and validated process.Halyard is the specification developer of the gloves contract manufactured by shandong intco medical products co., ltd.All raw materials used are consistent with those specified for medical-grade gloves.Reports of allergic reactions are considered to reflect individual risk manifestations during glove use, with occurrences that are sporadic and vary from person to person.Due to the nature of nitrile glove manufacturing which involves multiple chemical formulations and processing steps, trace levels of residual chemicals or surface substances may remain.Under typical conditions of use, these trace substances do not result in adverse effects; however, in sensitive individuals, they may trigger skin irritation or delayed hypersensitivity reactions.While the current manufacturing process incorporates risk control measures such as formulation optimization, controlled washing processes, and finished product inspections, it is not possible to completely eliminate the potential for reactions in users with heightened skin sensitivity through existing controls alone.A review of complaints received over the previous 12 months (b)(6) 2025) did not identify any trends, clusters, or recurring reports of allergy or skin irritation from this customer.In response to the current complaint, shandong intco medical products co., ltd.Has strengthened its internal controls by enhancing communication of similar cases and increasing employee awareness regarding the potential risk of allergic reactions associated with residual chemicals in finished gloves.Based on this comprehensive assessment, the root cause is determined to be a delayed-type contact skin reaction.The reaction was likely caused by an individual allergic predisposition, first-time exposure to this specific formulation, and a warm, humid, and occlusive environment inside the glove that softened the skin barrier and increased sensitivity.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: HALYARD SKYBREEZE POWDER-FREE NITRILE EXAM GLOVES M
• Common Device Name: NITRILE EXAM GLOVE
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; alpharetta GA 30005
• Manufacturer (Section G): SHANDONG INTCO MEDICAL PRODUCTS CO LTD; 9888 qiwang road; naoshan industrial park; qingzhou shandong, china 26250 0; CH 262500
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 25135111
• Report Number: 3014421917-2026-00011
• Device Sequence Number: 13090321
• Product Code: LZC
• UDI-Device Identifier: 30680651473753
• UDI-Public: 30680651473753
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 47375
• Device Catalogue Number: 47375
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female