Gloves

GUDID 00369771001501

GLOVES VINYL PF N/S XL

GERI-GENTLE CORPORATION

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 00369771001501
• NIH Device Record Key: 6c02fe06-03cd-46d8-abc0-1f6bc3df4743
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gloves
• Version Model Number: 12-309
• 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	00369771000627 [Unit of Use]
GS1	00369771001402 [Primary]
GS1	00369771001501 [Package]; Contains: 00369771001402; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093270

FDA Product Code

• LYZ: Vinyl 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