Gloves

GUDID 00369771001457

GLOVES NITRILE PF XL

GERI-GENTLE CORPORATION

Nitrile examination/treatment glove, non-powdered, non-sterile

• Primary Device ID: 00369771001457
• NIH Device Record Key: c640b3e8-2566-4669-b1b8-d38fa10e8d49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gloves
• Version Model Number: 12892
• Company DUNS: 361663839
• Company Name: GERI-GENTLE CORPORATION
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00369771000726 [Unit of Use]
GS1	00369771001440 [Primary]
GS1	00369771001457 [Package]; Contains: 00369771001440; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141303

FDA Product Code

• LZA: Polymer Patient Examination Glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-09
• Device Publish Date: 2019-09-01

On-Brand Devices [Gloves]

• 00369771001495: GLOVES NITRILE PF LG
• 00369771001471: GLOVES NITRILE PF SM
• 00369771001457: GLOVES NITRILE PF XL
• 00369771001433: GLOVES NITRILE PF MD
• 00369771001501: GLOVES VINYL PF N/S XL
• 00369771001396: GLOVES VINYL PF N/S LG
• 00369771001372: GLOVES VINYL PF N/S MD
• 00369771001280: GLOVES VINYL PF N/S SM