NUSA

GUDID 00810007662398

PF Nitrile Exam Gloves - S, 200/BX, Made In USA, Tested For Use With Chemotherapy Drugs and Fentanyl

HOURGLASS INTERNATIONAL INC

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

• Primary Device ID: 00810007662398
• NIH Device Record Key: af908adb-67a5-4467-b40d-22468394fbd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NUSA
• Version Model Number: 201
• Company DUNS: 026777252
• Company Name: HOURGLASS INTERNATIONAL 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: 800-277-0994
• Email: request@hourglass-intl.com
• Phone: 800-277-0994
• Email: request@hourglass-intl.com
• Phone: 800-277-0994
• Email: request@hourglass-intl.com
• Phone: 800-277-0994
• Email: request@hourglass-intl.com
• Phone: 800-277-0994
• Email: request@hourglass-intl.com
• Phone: 800-277-0994
• Email: request@hourglass-intl.com
• Phone: 800-277-0994
• Email: request@hourglass-intl.com
• Phone: 800-277-0994
• Email: request@hourglass-intl.com
• Phone: 800-277-0994
• Email: request@hourglass-intl.com
• Phone: 800-277-0994
• Email: request@hourglass-intl.com
• Phone: 800-277-0994
• Email: request@hourglass-intl.com
• Phone: 800-277-0994
• Email: request@hourglass-intl.com
• Phone: 800-277-0994
• Email: request@hourglass-intl.com
• Phone: 800-277-0994
• Email: request@hourglass-intl.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810007662299 [Unit of Use]
GS1	00810007662343 [Primary]
GS1	00810007662398 [Package]; Contains: 00810007662343; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233970

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: 2026-01-09
• Device Publish Date: 2026-01-01

On-Brand Devices [NUSA]

• 00810007662428: PF Nitrile Exam Gloves - XL, 190/BX, Made In USA, Tested For Use With Chemotherapy Drugs and Fen
• 00810007662411: PF Nitrile Exam Gloves - L, 200/BX, Made In USA, Tested For Use With Chemotherapy Drugs and Fent
• 00810007662404: PF Nitrile Exam Gloves - M, 200/BX, Made In USA, Tested For Use With Chemotherapy Drugs and Fent
• 00810007662398: PF Nitrile Exam Gloves - S, 200/BX, Made In USA, Tested For Use With Chemotherapy Drugs and Fent
• 00810007662381: PF Nitrile Exam Gloves - XS, 200/BX, Made In USA, Tested For Use With Chemotherapy Drugs and Fen