DEFENDER MAX

GUDID 00850031575332

Nitrile disposable 6 mil powder-free examination glove, 100 gloves per box. Medical Grade, Chemotherapy drug tested, Not made with Rubber Latex, Low Derma, Protection against Fentanyl, Single use, Non-sterile. Size is large.

Armstrong Medical Supply, LLC

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Primary Device ID	00850031575332
NIH Device Record Key	c0c14551-cf97-43f9-b381-dc8e1db9bcb6
Commercial Distribution Status	In Commercial Distribution
Brand Name	DEFENDER MAX
Version Model Number	AMSDEF6-L
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	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
Email	tcarter@armstrongmed.com
Phone	2819709411
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	00850031575271 [Primary]
GS1	00850031575332 [Package] Contains: 00850031575271 Package: case [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181857

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	2021-06-22
Device Publish Date	2021-06-14

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00850031575332	Nitrile disposable 6 mil powder-free examination glove, 100 gloves per box. Medical Grade, Chemo
00850031575325	Nitrile disposable 6 mil powder-free examination glove, 100 gloves per box. Medical Grade, Chemo
00850031575318	Nitrile disposable 6 mil powder-free examination glove, 100 gloves per box. Medical Grade, Chemo
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