Firm Touch

GUDID 00810007198835

Elite Safety Products

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

• Primary Device ID: 00810007198835
• NIH Device Record Key: cc35dc7e-887d-46a2-ac18-845192ea1441
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Firm Touch
• Version Model Number: 6550MD (S)
• Company DUNS: 082745034
• Company Name: Elite Safety Products
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810007198835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110981

FDA Product Code

• FMC: 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: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [Firm Touch]

• 00810101520495: 6040BMD (2XL)
• 00810007198828: 6040BMD (S)
• 00810007198682: 6040BMD (XL)
• 00810007198675: 6040BMD (L)
• 00810007198668: 6040BMD (M)
• 00810101520556: 6540MD/2XL
• 00810101520549: 6540MD/XL
• 00810101520532: 6540MD/L
• 00810101520525: 6540MD/M
• 00810101520518: 6540MD/S
• 00810007198835: 6550MD (S)
• 00810007198712: 6550MD (XL)
• 00810007198705: 6550MD (L)
• 00810007198699: 6550MD (M)