Device
Powder-Free Vinyl Examination Gloves
Manufacturer
Unisafe Inc.
Model: PGV500L DI: 00811114031619 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: No
First Published: 2026-05-20 Current Version: 2026-05-28
Description
Powder-Free Vinyl Examination Gloves
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 812d49bf-e5d1-44aa-9774-2202cf45b4aa
Distribution Status: In Commercial Distribution
DUNS Number: 080171627
Device Count: 100
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Device ID: 10811114031616
Item #1 - Device ID Type: Unit of Use
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00811114031619
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Pkg Type: Shipper Carton
Item #3 - Device ID: 00811114031657
Item #3 - Pkg Status: In Commercial Distribution
Item #3 - Pkg Quantity: 10
Item #3 - Device ID Type: Package
Item #3 - Contains DINumber: 00811114031619
Item #3 - Device ID Issuing Agency: GS1
GMDN
Code: 47176
Name: Vinyl examination/treatment glove, non-powdered
Definition:
A non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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.
FDA Product Codes
LYZ
Vinyl Patient Examination Glove