DEFENDER

GUDID 00850031575004

Nitrile disposable 4 mil powder-free examination gloves, 100 gloves per box. Medical Grade, Chemotherapy drug tested, Not made with Rubber Latex, Low Derma, Protection against Fentanyl, Single use, Non-sterile. X-Small size.

Armstrong Medical Supply, LLC

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

• Primary Device ID: 00850031575004
• NIH Device Record Key: 23a76916-d8ef-4056-9465-3855cba419b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEFENDER
• Version Model Number: AMSDEF4-XS
• Company DUNS: 962708454
• Company Name: Armstrong Medical Supply, LLC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com
• Phone: 281.970.9411
• Email: tcarter@armstrongmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 65 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850031575004 [Primary]
GS1	00850031575066 [Package]; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181857

FDA Product Code

• QDO: Fentanyl And Other Opioid Protection 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: 2021-05-28
• Device Publish Date: 2021-05-20

On-Brand Devices [DEFENDER]

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• 00850031575042: Nitrile disposable 4 mil powder-free examination glove, 100 gloves per box. Medical Grade, Chemo
• 00850031575035: Nitrile disposable 4 mil powder-free examination glove, 100 gloves per box. Medical Grade, Chemo
• 00850031575028: Nitrile disposable 4 mil powder-free examination glove, 100 gloves per box. Medical Grade, Chemo
• 00850031575011: Nitrile disposable 4 mil powder-free examination glove, 100 gloves per box. Medical Grade, Chemo
• 00850031575004: Nitrile disposable 4 mil powder-free examination gloves, 100 gloves per box. Medical Grade, Chem