Great Glove

GUDID B754SBLKNM520E1

Black Nitrile Powder Free Medical Gloves Size Extra Large

GD CARE INC.

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

• Primary Device ID: B754SBLKNM520E1
• NIH Device Record Key: c411689f-671e-4d11-8fb7-5700a4fe2eac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Great Glove
• Version Model Number: SBLK-NM520E
• Company DUNS: 080925610
• Company Name: GD CARE INC.
• Device Count: 1
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B754SBLKNM520E0 [Primary]
HIBCC	B754SBLKNM520E1 [Package]; Contains: B754SBLKNM520E0; Package: Inner [95 Units]; In Commercial Distribution
HIBCC	B754SBLKNM520E2 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182528

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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Great Glove]

• B754SBLKNM520E1: Black Nitrile Powder Free Medical Gloves Size Extra Large
• B754SBLKNM515E1: Black Nitrile Powder Free Medical Gloves Size Large
• B754SBLKNM510E1: Black Nitrile Powder Free Medical Gloves Size Medium
• B754SBLKNM505E1: Black Nitrile Powder Free Medical Gloves Size Small
• B754SBLKNM500E1: Black Nitrile Powder Free Medical Gloves Size Extra Small
• B754SNM50020E1: Soft Nitrile Powder Free Medical Gloves Size Extra Large
• B754SNM50015E1: Soft Nitrile Powder Free Medical Gloves Size Large
• B754SNM50010E1: Soft Nitrile Powder Free Medical Gloves Size Medium
• B754SNM50005E1: Soft Nitrile Powder Free Medical Gloves Size Small
• B754NM50025E1: Nitrile Powder Free Medical Gloves Size Extra Extra Large
• B754NM50020E1: Nitrile Powder Free Medical Gloves Size Extra Large
• B754NM50015E1: Nitrile Powder Free Medical Gloves Size Large
• B754NM50010E1: Nitrile Powder Free Medical Gloves Size Medium
• B754NM50005E1: Nitrile Powder Free Medical Gloves Size Small
• B754SNM50015E0: Soft Nitrile Powder Free Medical Gloves Size Large