Xpect

GUDID 10850047958997

Polymer Patient Exam Gloves Large

Cintas Corporation No. 2

Surgical/examination garment kit

• Primary Device ID: 10850047958997
• NIH Device Record Key: 5142eba7-fdf3-400e-ba35-137d1d0e385c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpect
• Version Model Number: 182309
• Company DUNS: 118376317
• Company Name: Cintas Corporation No. 2
• Device Count: 8
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)
• Special Storage Condition, Specify: Between 0 and 0 *Do not store above 100 F (38 C)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850047958990 [Primary]
GS1	10850047958997 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121526

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: 2023-11-13
• Device Publish Date: 2023-11-03

On-Brand Devices [Xpect]

• 10850047958997: Polymer Patient Exam Gloves Large
• 00850053907142: Naloxone Opioid Overdose Kit