PremierPro 5064Recalls & reported problems

Prestige Ameritech, Ltd. · PremierPro Plus Improved Thinner Technology Nitrile Exam Glove Large 200count · Class 1

All models of PremierPro (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818566011039), received between Sep 16, 2024 and Sep 16, 2024 — classified as 1 malfunction.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 16, 2024
GLOVES RIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20223642 ↗

Device details

UDI-DI	`00818566011039`
Brand	PremierPro
Model	5064
Company	Prestige Ameritech, Ltd.
Product code	LZC · Patient Examination Glove, Specialty
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 23, 2026

Device type (GMDN): Nitrile examination/treatment glove, non-powdered, non-antimicrobial

A device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Other Patient Examination Glove, Specialty devices

PremierPro D5061
Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty
1 recall0 reports
PremierPro D5064
Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty
1 recall0 reports
PremierPro D5063
Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty
1 recall0 reports
PremierPro D5062
Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty
1 recall0 reports
PremierPro D5065
Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty
1 recall0 reports
Halyard 55090
O&M Halyard, Inc. · Patient examination glove, specialty
2 reports
Halyard 47375
O&M Halyard, Inc. · Patient examination glove, specialty
2 reports
PremierPro 5063
Prestige Ameritech, Ltd. · Patient Examination Glove, Specialty
1 report

All Patient Examination Glove, Specialty devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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