Layer4 3915-2200

GUDID 00850064227031

Layer4 Comfort Nitrile Exam Gloves Small 200 per Box

Usa Scientific, 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

• Primary Device ID: 00850064227031
• NIH Device Record Key: 2f4ad0a1-3946-48a9-b9d0-877182cda937
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Layer4
• Version Model Number: 3915-2200
• Catalog Number: 3915-2200
• Company DUNS: 106947237
• Company Name: Usa Scientific, Inc.
• Device Count: 200
• 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: 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

Customer Support Contacts

• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com
• Phone: 352-237-6288
• Email: info@usascientific.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850064227024 [Primary]
GS1	00850064227031 [Package]; Contains: 00850064227024; Package: Case [10 Units]; In Commercial Distribution
GS1	10850064227007 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102790

FDA Product Code

• LZC: Medical Glove, Specialty

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: 2024-05-15
• Device Publish Date: 2024-05-07

On-Brand Devices [Layer4]

• 00850064227192: Layer4 RapidDon Nitrile Exam Gloves X-Large 230 per Box
• 10850064227168: Layer4 RapidDon Nitrile Exam Gloves Large 250 per Box
• 00850064227154: Layer4 RapidDon Nitrile Exam Gloves Medium 250 per Box
• 00850064227130: Layer4 RapidDon Nitrile Exam Gloves Small 250 per Box
• 00850064227116: Layer4 RapidDon Nitrile Exam Gloves X-Small 250 per Box
• 00850064227093: Layer4 Comfort Nitrile Exam Gloves X-Large 200 per Box
• 00850064227079: Layer4 Comfort Nitrile Exam Gloves Large 200 per Box
• 00850064227055: Layer4 Comfort Nitrile Exam Gloves Medium 200 per Box
• 00850064227031: Layer4 Comfort Nitrile Exam Gloves Small 200 per Box
• 00850064227000: Layer4 Comfort Nitrile Exam Gloves X-Small 200 per Box