Dental Mates

GUDID 00860009046412

M.Y.T. USA Corp.

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

• Primary Device ID: 00860009046412
• NIH Device Record Key: 716d31c0-c11b-41fc-86e5-56305fed1de2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Mates
• Version Model Number: Size Small
• Company DUNS: 118764392
• Company Name: M.Y.T. USA Corp.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 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
GS1	00860009046412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152720

FDA Product Code

• FMC: Patient Examination Glove

Sterilization

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

[00860009046412]

High-level Disinfectant

[00860009046412]

High-level Disinfectant

[00860009046412]

High-level Disinfectant

[00860009046412]

High-level Disinfectant

[00860009046412]

High-level Disinfectant

[00860009046412]

High-level Disinfectant

[00860009046412]

High-level Disinfectant

[00860009046412]

High-level Disinfectant

[00860009046412]

High-level Disinfectant

[00860009046412]

High-level Disinfectant

[00860009046412]

High-level Disinfectant

[00860009046412]

High-level Disinfectant

[00860009046412]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-25
• Device Publish Date: 2022-08-17

On-Brand Devices [Dental Mates]

• 00860009046450: ASTM LEVEL 3 MASK
• 00860009046443: Size XL
• 00860009046436: Size Large
• 00860009046429: Size Medium
• 00860009046412: Size Small
• 00860009046405: Size XS
• 00840169153533: LATEX EXAM GLOVES SIZE XS
• 00840169153571: LATEX EXAM GLOVES SIZE XL
• 00840169153564: LATEX EXAM GLOVES SIZE LARGE
• 00840169153557: LATEX EXAM GLOVES SIZE MEDIUM
• 00840169153540: LATEX EXAM GLOVES SIZE SMALL
• 00860009046481: Sterilization Pouches
• 00860009046474: Sterilization Pouches
• 00860009046467: Sterilization Pouches
• 00840169153793: Sterilization Pouches