FDA.reportPublic FDA data

Armor One

Primary DI
00860007772306
Brand
Armor One
Company
Solace Trading LLC
Model
CL8032 - Small - 100 PCS
Published
2021-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007772306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007772306008600077723068600077723060860007772306

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
099838040
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007772344FIRST LINELATEX GLOVES - SMALL - CL8060L - 100 PCS2022-04-30
00860007772351FIRST LINELATEX GLOVES - MEDIUM - CL8060L - 100 PCS2022-04-30
00860007772368FIRST LINELATEX GLOVES - LARGE - CL8060L - 100 PCS2022-04-30
00860007772375FIRST LINELATEX GLOVES - EXTRA-LARGE - CL8060L - 100 PCS2022-04-30
00860007772313Armor OneCL8032 - Medium - 100 PCS2021-12-03
00860007772320Armor OneCL8032 - Large - 100 PCS2021-12-03
00860007772337Armor OneCL8032 - X-Large - 100 PCS2021-12-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860015678959UCKER1ST TRY, CORPLZA2026-05-22
00860015678966UCKER1ST TRY, CORPLZA2026-05-22
00860015678973UCKER1ST TRY, CORPLZA2026-05-22
10194346659194EquateWAL-MART STORES, INC.LZA2026-03-24
10194346659200EquateWAL-MART STORES, INC.LZA2026-03-24
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