Medical device shortage: OmniFLEX Powder-Free Nitrile Medical Examination Gloves

The OmniFLEX Powder-Free Nitrile Medical Examination Gloves is currently reported as a medical device shortage through Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. Interim Order No. 2 repeals and replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19 (the previous interim order) made by the Minister on March 30, 2020. For a full list of shortages, refer to the list of medical device shortages.

Posted on 2021-04-13

Type of report

Actual medical device shortage

Name of medical device (including any component, accessory, or part that is in shortage, including the model name) if applicable

OmniFLEX Powder-Free Nitrile Medical Examination Gloves

Other names (for example trade name), if applicable

n/a

Package description (for example, packaging formats, sizes, quantities)

100 per box

Class of medical device (I, II, III or IV), if known

Class II

Device identifier(s) (for example, serial number, catalogue number, part number, model number or unique device identifier)

012-097 XS; 012-107 S; 012-117 M; 012-127 L; 012-137 XL

Medical device licence number (for Class II, III and IV), if applicable

23823

Authorization identification number (for devices authorized for importation or sale under an interim order made under section 30.1 of the Food and Drugs Act), if applicable

n/a

Single-use product

Yes

Manufacturer's name

AMG Medical Inc.

Manufacturer's mailing address

8505 Dalton
Montreal, QC
H4T 1V5

Reason for shortage

Increase in demand for the medical device