WellBefore

GUDID 00850044566006

Social Medical Supply LLC

Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit

• Primary Device ID: 00850044566006
• NIH Device Record Key: dc478b39-ba0f-496e-aa66-17384720609c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WellBefore
• Version Model Number: O1_NITRILE_4.0_LARGE
• Company DUNS: 118056777
• Company Name: Social Medical Supply LLC
• 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: 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	00850044566006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152720

FDA Product Code

• LZA: Polymer Patient Examination Glove

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-29
• Device Publish Date: 2023-05-19

On-Brand Devices [WellBefore]

• 00850046808722: O9_10-BOXES_VINYL-BLACK_XLARGE
• 00850046808715: O9_10-BOXES_VINYL-BLACK_LARGE
• 00850046808708: O9_10-BOXES_VINYL-BLACK_MEDIUM
• 00850046808692: O9_10-BOXES_VINYL-BLACK_SMALL
• 00850046808678: O8_10-BOXES_VINYL-BLUE_XLARGE
• 00850046808661: O8_10-BOXES_VINYL-BLUE_LARGE
• 00850046808654: O8_10-BOXES_VINYL-BLUE_MEDIUM
• 00850046808647: O8_10-BOXES_VINYL-BLUE_SMALL
• 00850046808623: O7_10-BOXES_VINYL-CLEAR_XLARGE
• 00850046808616: O7_10-BOXES_VINYL-CLEAR_LARGE
• 00850046808609: O7_10-BOXES_VINYL-CLEAR_MEDIUM
• 00850046808593: O7_10-BOXES_VINYL-CLEAR_SMALL
• 00850046808203: O9_VINYL-BLACK_XLARGE
• 00850046808197: O9_VINYL-BLACK_LARGE
• 00850046808180: O9_VINYL-BLACK_MEDIUM
• 00850046808173: O9_VINYL-BLACK_SMALL
• 00850046808166: O8_VINYL-BLUE_XLARGE
• 00850046808159: O8_VINYL-BLUE_LARGE
• 00850046808142: O8_VINYL-BLUE_MEDIUM
• 00850046808135: O8_VINYL-BLUE_SMALL
• 00850046808128: O7_VINYL-CLEAR_XLARGE
• 00850046808111: O7_VINYL-CLEAR_LARGE
• 00850046808104: O7_VINYL-CLEAR_MEDIUM
• 00850046808098: O7_VINYL-CLEAR_SMALL
• 00850046808043: O1_NITRILE_4.0_XSMALL
• 00850046808036: O6_NITRILE-BLACK_4.0_XSMALL
• 00850044566952: O6_NITRILE-BLACK_4.0_SMALL
• 00850044566945: O6_NITRILE-BLACK_4.0_MEDIUM
• 00850044566938: O6_NITRILE-BLACK_4.0_XLARGE
• 00850044566921: O6_NITRILE-BLACK_4.0_LARGE
• 00850044566112: O1_NITRILE_4.0_XLARGE
• 00850044566099: O5_NITRILE-BLEND_5.2_XLARGE
• 00850044566082: O1_NITRILE_4.0_MEDIUM
• 00850044566044: O5_NITRILE-BLEND_5.2_MEDIUM
• 00850044566037: O1_NITRILE_4.0_SMALL
• 00850044566020: O5_NITRILE-BLEND_5.2_LARGE
• 00850044566013: O5_NITRILE-BLEND_5.2_SMALL
• 00850044566006: O1_NITRILE_4.0_LARGE