SAFETY MAX GOLD

GUDID 00850048332003

LARGE Nitrile Medical Examination Gloves, Latex free, 4.5MIL 100 pieces per box 10 boxes per case 1000 pieces per case

Pristine Dental Supplies, Inc.

Nitrile examination/treatment glove, non-powdered, antimicrobial

• Primary Device ID: 00850048332003
• NIH Device Record Key: e194a308-af12-47e6-af0f-014bde389144
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAFETY MAX GOLD
• Version Model Number: SMN-45-L
• Company DUNS: 080057154
• Company Name: Pristine Dental Supplies, Inc.
• 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: 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
GS1	00850048332003 [Unit of Use]
GS1	00850048332485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202384

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: 2023-03-27
• Device Publish Date: 2023-03-18

On-Brand Devices [SAFETY MAX GOLD]

• 00850048332003: LARGE Nitrile Medical Examination Gloves, Latex free, 4.5MIL 100 pieces per box 10 boxes per cas
• 00850048332225: XSMALL Nitrile Medical Examination Gloves, Latex free, 4.5MIL 100 pieces per box 10 boxes per c
• 00850048332027: SMALL Nitrile Examination Gloves, Latex free, 4.5MIL 100 pieces per box 10 boxes per case 1000 p
• 00850048332034: MEDIUM Nitrile Medical Examination Gloves, Latex free, 4.5MIL 100 pieces per box 10 boxes per ca
• 00850048332232: XLARGE Nitrile Medical Examination Gloves, Latex free, 4.5MIL 100 pieces per box 10 boxes per ca