Polysilk

GUDID 00641932180141

Shamrock 18000 Black Latex Examination Powder Free Textured Gloves, Xlarge

Shamrock Marketing Co., Inc.

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

• Primary Device ID: 00641932180141
• NIH Device Record Key: 965ff701-416b-472f-bf2c-72e7af738ac2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polysilk
• Version Model Number: 18014
• Company DUNS: 010206618
• Company Name: Shamrock Marketing Co., Inc.
• Device Count: 1
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00641932180141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062709

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: 2022-07-15
• Device Publish Date: 2022-07-07

On-Brand Devices [Polysilk]

• 00641932180141: Shamrock 18000 Black Latex Examination Powder Free Textured Gloves, Xlarge
• 00641932180134: Shamrock 18000 Black Latex Examination Powder Free Textured Gloves, Large
• 00641932180127: Shamrock 18000 Black Latex Examination Powder Free Textured Gloves, Medium
• 00641932180110: Polysilk18000 Black Latex Examination Powder Free Textured Gloves, Small