UTILITY GLOVE 40-060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-08 for UTILITY GLOVE 40-060 manufactured by Hu-friedy Mfg Co., Inc..

Event Text Entries

[17723906] Osha and the cdc require the use of puncture-resistant, heavy-duty utility gloves in the instrument processing area in the dental healthcare setting. Hu-friedy lilac utility gloves -#40-060- are identified by hu-friedy on its website and markets these gloves through dental supply companies as puncture-resistant utility gloves. The packaging for these gloves states that they are "puncture resistant. " i emailed hu-friedy to determine if these gloves are certified as puncture-resistant by osha and the cdc. They never responded to my info request. Clinically, i know that these gloves are not puncture-resistant: a 20 gauge or 23 gauge needle passes through them with virtually no resistance. The use of non-puncture-resistant utility gloves by healthcare workers believing that these gloves are puncture-resistant when they are noncompliant with osha and the cdc regulations is not only fraudulent, it is unhealthy and dangerous. The fda should stop hu-friedy from misrepresenting these gloves as puncture resistant and they should recall these gloves for the safety hazard that they present to healthcare workers.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5018147
• MDR Report Key: 1898480
• Date Received: 2010-11-08
• Date of Report: 2010-11-08
• Date Added to Maude: 2010-11-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UTILITY GLOVE 40-060
• Generic Name: INSTRUMENT PROCESSING UTILITY GLOVE
• Product Code: LYY
• Date Received: 2010-11-08
• Model Number: 40-060
• ID Number: M154400600
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HU-FRIEDY MFG CO., INC.
• Manufacturer Address: 3232 N ROCKWELL ST CHICAGO IL 60618 US 60618

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-11-08