FreeStyle

GUDID 00810007660370

Nitrile Powder Free Examination Gloves, XL, Tested for Use with Chemotherapy Drugs.

HOURGLASS INTERNATIONAL INC

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

• Primary Device ID: 00810007660370
• NIH Device Record Key: c2cbc10d-ad61-4447-9907-835eb86f5143
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle
• Version Model Number: 1104
• Company DUNS: 026777252
• Company Name: HOURGLASS INTERNATIONAL INC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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	00810007660370 [Unit of Use]
GS1	10810007660377 [Primary]

FDA Product Code

• LZC: Patient Examination 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: 2021-12-09
• Device Publish Date: 2021-12-01

On-Brand Devices [FreeStyle]

• 10810007660391: Nitrile Powder Free Examination Gloves, XXS, Tested for Use with Chemotherapy Drugs.
• 10810007660384: Nitrile Powder Free Examination Gloves, XXL, Tested for Use with Chemotherapy Drugs.
• 10810007660377: Nitrile Powder Free Examination Gloves, XL, Tested for Use with Chemotherapy Drugs.
• 10810007660360: Nitrile Powder Free Examination Gloves, L, Tested for Use with Chemotherapy Drugs.
• 10810007660353: Nitrile Powder Free Examination Gloves, M, Tested for Use with Chemotherapy Drugs.
• 10810007660346: Nitrile Powder Free Examination Gloves, S, Tested for Use with Chemotherapy Drugs.
• 10810007660339: Nitrile Powder Free Examination Gloves, XS, Tested for Use with Chemotherapy Drugs.
• 00810007660394: Nitrile Powder Free Examination Gloves, XXS, Tested for Use with Chemotherapy Drugs.
• 00810007660387: Nitrile Powder Free Examination Gloves, XXL, Tested for Use with Chemotherapy Drugs.
• 00810007660370: Nitrile Powder Free Examination Gloves, XL, Tested for Use with Chemotherapy Drugs.
• 00810007660363: Nitrile Powder Free Examination Gloves, L, Tested for Use with Chemotherapy Drugs.
• 00810007660356: Nitrile Powder Free Examination Gloves, M, Tested for Use with Chemotherapy Drugs.
• 00810007660349: Nitrile Powder Free Examination Gloves, S, Tested for Use with Chemotherapy Drugs.
• 00810007660332: Nitrile Powder Free Examination Gloves, XS, Tested for Use with Chemotherapy Drugs.