Vinyl Exam Gloves (Powder Free) Size: Large

GUDID 80368001109075

BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 80368001109075
• NIH Device Record Key: 97422f6a-7025-48eb-af88-bb02f560857d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vinyl Exam Gloves (Powder Free) Size: Large
• Version Model Number: 10907
• Company DUNS: 985523874
• Company Name: BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00368001109079 [Primary]
GS1	60368001109071 [Package]; Contains: 00368001109079; Package: Case [10 Units]; In Commercial Distribution
GS1	80368001109075 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102444
• Premarket Notification: K131832

FDA Product Code

• LYZ: Vinyl 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: 2022-03-14
• Device Publish Date: 2022-03-04

Devices Manufactured by BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY

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• 60368001101297 - Amerisource Bergen: 2025-04-09 Sterile Latex Surgical Gloves Powder Free Size: 7
• 00368001101301 - Amerisource Bergen: 2025-04-09 Sterile Latex Surgical Gloves Powder Free Size: 7.5
• 00368001101318 - Amerisource Bergen: 2025-04-09 Sterile Latex Surgical Gloves Powder Free Size:8.0
• 80368001101321 - Amerisource Bergen: 2025-04-09 Sterile Latex Surgical Gloves Powder Free Size:8.5
• 60368001101334 - Amerisource Bergen: 2025-04-09 Sterile Latex Surgical Gloves Powder Free Size: 9.0