Bodyguard

GUDID 30662956500471

XL SERIES 814E 4 MIL BLUE NITRILE EXAM GRADE POWDER-FREE BODY GUARD[REG] DISPOSABLE GLOVE

Fastenal Company

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

• Primary Device ID: 30662956500471
• NIH Device Record Key: 10fc3e17-676e-4292-b1de-608efce1f091
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bodyguard
• Version Model Number: XL-816E
• Company DUNS: 042653634
• Company Name: Fastenal Company
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• 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	00662956500470 [Primary]
GS1	30662956500471 [Package]; Contains: 00662956500470; Package: box [100 Units]; In Commercial Distribution
GS1	50662956500475 [Package]; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202356
• Premarket Notification: K212578

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: 2025-03-03
• Device Publish Date: 2025-02-21

On-Brand Devices [Bodyguard]

• 03066295694406: 816EI
• 30662956935570: 815 BK XL
• 30662956935556: 815 BK S
• 00662956390170: 815 BK L
• 30662956935563: 815 BK M
• 00662956211550: 816EI VP
• 30662956500471: XL SERIES 814E 4 MIL BLUE NITRILE EXAM GRADE POWDER-FREE BODY GUARD[REG] DISPOSABLE GLOVE
• 30662956500464: LARGE SERIES 814E 4 MIL BLUE NITRILE EXAM GRADE POWDER-FREE BODY GUARD[REG] DISPOSABLE GLOVE
• 30662956500457: MEDIUM SERIES 814E 4 MIL BLUE NITRILE EXAM GRADE POWDER-FREE BODY GUARD[REG] DISPOSABLE GLOVE
• 30662956500433: SMALL SERIES 814E 4 MIL BLUE NITRILE EXAM GRADE POWDER-FREE BODY GUARD[REG] DISPOSABLE GLOVE