Annuy Powder-free Nitrile Patient Examination Glove

GUDID 26928965100055

A non-sterile 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.

Anhui Annuy Latex Products Co.,Ltd.

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

• Primary Device ID: 26928965100055
• NIH Device Record Key: a9033ebb-ab2e-446a-ad97-f8ee319ecc8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Annuy Powder-free Nitrile Patient Examination Glove
• Version Model Number: M
• Company DUNS: 421347466
• Company Name: Anhui Annuy Latex Products Co.,Ltd.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06928965100051 [Unit of Use]
GS1	16928965100058 [Primary]
GS1	26928965100055 [Package]; Contains: 16928965100058; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150612

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: 2021-02-03
• Device Publish Date: 2021-01-26

On-Brand Devices [Annuy Powder-free Nitrile Patient Examination Glove]

• 06928965100068: A non-sterile device made of Nitrile intended as a protective barrier when worn on the hands of
• 26928965100055: A non-sterile device made of Nitrile intended as a protective barrier when worn on the hands of
• 26928965100048: A non-sterile device made of Nitrile intended as a protective barrier when worn on the hands of