Vinyl Exam Gloves (Powder Free) Size: Extra Large

GUDID 80368001109082

BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY

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• Primary Device ID: 80368001109082
• NIH Device Record Key: 1aac0767-ca38-4faa-9913-0f95daab0993
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vinyl Exam Gloves (Powder Free) Size: Extra Large
• Version Model Number: 10908
• 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	00368001109086 [Primary]
GS1	60368001109088 [Package]; Contains: 00368001109086; Package: Case [10 Units]; In Commercial Distribution
GS1	80368001109082 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• 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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• 60368001100603 - AmerisourceBergen: 2023-03-23 Nitrile Exam Gloves, Powder Free, Premium 5, Size: Large
• 60368001114051 - Amerisource Bergen: 2022-11-03 Disposable Underpads Premium 23inX36in ( 58.4gm X 91.4cm)
• 80368001109099 - AmerisourceBergen: 2022-07-18 Vinyl Exam Gloves Stretch Powder Free (SMALL)
• 80368001109105 - AmerisourceBergen: 2022-07-18 Vinyl Exam Gloves Stretch Powder Free (Medium)
• 80368001109112 - AmerisourceBergen: 2022-07-18 Vinyl Exam Gloves Stretch Powder Free (Large)
• 80368001109129 - AmerisourceBergen: 2022-07-18 Vinyl Exam Gloves Stretch Powder Free (X-Large)