QUALATEX LEGPPS

GUDID 09555697505105

Powdered Latex Examination Gloves Size: XL

TAN SIN LIAN INDUSTRIES SDN. BHD.

Hevea-latex examination/treatment glove, powdered

• Primary Device ID: 09555697505105
• NIH Device Record Key: c33c362d-25bf-49f3-a043-ee7f71fcdc4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUALATEX
• Version Model Number: LEGPPS XL
• Catalog Number: LEGPPS
• Company DUNS: 596473983
• Company Name: TAN SIN LIAN INDUSTRIES SDN. BHD.
• 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: false
• 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

• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09555697505105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992557

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: 2023-07-12
• Device Publish Date: 2023-07-04

On-Brand Devices [QUALATEX]

• 09555697505150: Powder Free Latex Examination Gloves Size: XL
• 09555697505143: Powder Free Latex Examination Gloves Size: L
• 09555697505136: Powder Free Latex Examination Gloves Size: M
• 09555697505129: Powder Free Latex Examination Gloves Size: S
• 09555697505112: Powder Free Latex Examination Gloves Sizes: XS
• 09555697505105: Powdered Latex Examination Gloves Size: XL
• 09555697505099: Powdered Latex Examination Gloves Size: L
• 09555697505082: Powdered Latex Examination Gloves Size: M
• 09555697505075: Powdered Latex Examination Gloves Size: S
• 09555697505068: Powdered Latex Examination Gloves Size XS