Cap'n K

GUDID 00810101520105

Elite Safety Products

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

• Primary Device ID: 00810101520105
• NIH Device Record Key: 9b857681-ecf0-4093-98f8-86af89e7e7cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cap'n K
• Version Model Number: 09-MWSPN-XL
• 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	00810101520105 [Primary]
GS1	00810101520143 [Package]; Package: Case [10 Units]; In Commercial Distribution

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: 2022-08-08
• Device Publish Date: 2022-07-31