RESIST

GUDID 00850053354601

RESIST Nitrile Exam Glove, 6.0mil, Black, Size X-Large, Chemo-Tested, Single Use, Box of 100

Poss, LLC

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

• Primary Device ID: 00850053354601
• NIH Device Record Key: 8f1f1a30-7d5a-4961-b126-7f816090c7fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESIST
• Version Model Number: RST350
• Company DUNS: 066882769
• Company Name: Poss, LLC
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850053354588 [Unit of Use]
GS1	00850053354595 [Primary]
GS1	00850053354601 [Package]; Contains: 00850053354595; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133307

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: 2023-10-09
• Device Publish Date: 2023-10-01

On-Brand Devices [RESIST]

• 00850053354601: RESIST Nitrile Exam Glove, 6.0mil, Black, Size X-Large, Chemo-Tested, Single Use, Box of 100
• 00850053354571: RESIST Nitrile Exam Glove, 6.0mil, Black, Size Large, Chemo-Tested, Single Use, Box of 100
• 00850053354540: RESIST Nitrile Exam Glove, 6.0mil, Black, Size Medium, Chemo-Tested, Single Use, Box of 100
• 00850053354519: RESIST Nitrile Exam Glove, 6.0mil, Black, Size Small, Chemo-Tested, Single Use, Box of 100