Advancare

GUDID B845ANBM100353

Intco Medical Industries, Inc.

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

• Primary Device ID: B845ANBM100353
• NIH Device Record Key: 63e5f3d1-409c-4f50-8c40-e5087e7d1389
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advancare
• Version Model Number: ANBM10035
• Company DUNS: 080162537
• Company Name: Intco Medical Industries, Inc.
• 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: 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
HIBCC	B845ANBM10035 [Unit of Use]
HIBCC	B845ANBM100351 [Primary]
HIBCC	B845ANBM100353 [Package]; Contains: B845ANBM100351; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170136

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: 2023-11-23
• Device Publish Date: 2023-11-15

On-Brand Devices [Advancare]

• B845ANBM100373: ANBM10037
• B845ANBM100363: ANBM10036
• B845ANBM100353: ANBM10035
• B845ANBM100343: ANBM10034
• B845ANBM100333: ANBM10033
• B845ANBM200173: ANBM20017
• B845ANBM200163: ANBM20016
• B845ANBM200153: ANBM20015
• B845ANBM200143: ANBM20014
• B845ANBM200133: ANBM20013
• B845ANBM100173: ANBM10017
• B845ANBM10016: ANBM10016
• B845ANBM10015: ANBM10015
• B845ANBM100133: ANBM10013