BLK JW9770XL

GUDID 00724351999379

Nitrile Powder Free Examination Glove, Black

Austin Pang Gloves Mfg (u.s.a.) Corp.

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

• Primary Device ID: 00724351999379
• NIH Device Record Key: a9d0d56b-96e3-48e9-8ad4-5042b77168e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLK
• Version Model Number: JW9770XL
• Catalog Number: JW9770XL
• Company DUNS: 072794423
• Company Name: Austin Pang Gloves Mfg (u.s.a.) Corp.
• Device Count: 100
• 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: false
• 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

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724351255277 [Unit of Use]
GS1	00724351999379 [Package]; Contains: 00724351999416; Package: Case [10 Units]; In Commercial Distribution
GS1	00724351999416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182528

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: 2023-11-29
• Device Publish Date: 2023-11-21

On-Brand Devices [BLK]

• 00724351999409: Nitrile Powder Free Examination Glove, Black
• 00724351999393: Nitrile Powder Free Examination Glove, Black
• 00724351999386: Nitrile Powder Free Examination Glove, Black
• 00724351999379: Nitrile Powder Free Examination Glove, Black
• 00724351231516: Nitrile Powder Free Examination Glove, Black