Pure Grip G2 1125531

GUDID 20304040131439

Pure Grip G2 PF Latex Glove X-SMALL

HENRY SCHEIN, INC.

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 20304040131439
• NIH Device Record Key: b4ad81e3-7eda-4151-bb99-979f06966d55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pure Grip G2
• Version Model Number: 1125531
• Catalog Number: 1125531
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 100
• DM Exempt: true
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040131435 [Unit of Use]
GS1	10304040131432 [Primary]
GS1	20304040131439 [Package]; Contains: 10304040131432; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970770

FDA Product Code

• LYY: Latex 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: 2020-06-23
• Device Publish Date: 2020-06-15

On-Brand Devices [Pure Grip G2]

• 20304040101920: Pure Grip G2 X-Large
• 20304040101913: Pure Grip G2 Large
• 20304040101906: Pure Grip G2 Medium
• 20304040101890: Pure Grip G2 Small
• 20304040101883: Pure Grip G2 X-Small
• H65811255352: Pure Grip G2 X-Large
• H65811255342: Pure Grip G2 Large
• H65811255332: Pure Grip G2 Medium
• H65811255322: Pure Grip G2 Small
• H65811255312: Pure Grip G2 X-Small
• 20304040132207: Pure Grip G2 X-Large
• 20304040132191: Pure Grip G2 Medium
• 20304040132184: Pure Grip G2 Small
• 20304040132177: Pure Grip G2 Large
• 20304040131477: Pure Grip G2 PF Latex Glove X-LARGE
• 20304040131460: Pure Grip G2 PF Latex Glove MEDIUM
• 20304040131453: Pure Grip G2 PF Latex Glove SMALL
• 20304040131446: Pure Grip G2 PF Latex Glove LARGE
• 20304040131439: Pure Grip G2 PF Latex Glove X-SMALL
• 20304040004658: Pure Grip G2 X-Small