FDA.reportPublic FDA data

Coregloves

Primary DI
00860010506905
Brand
Coregloves
Company
SMARTLOGICS LLC
Model
CGM-LC-XS-00000000001
Catalog number
CGM-LC-XS-01
Device description
Medical Power Nitrile Gloves - Long Cuff - Size XS
Published
2023-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
OPAPowder-Free Non-Natural Rubber Latex Surgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
OPAPowder-Free Non-Natural Rubber Latex Surgeon'S Gloves

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010506905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010506905008600105069058600105069050860010506905

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, 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; it includes an antimicrobial or antiviral agent/properties to reduce viable-microbe transmission/exposure and its inner surface is not covered with powder. 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store your gloves in a cool, dry place, and protect them from exposure to direct sunlight or fluorescent lighting.”

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125327611
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010506912CoreglovesCGM-XL-00000000001CGM-XL-012023-09-06
00860010506929CoreglovesCGM-L-00000000001CGM-L-012023-09-06
00860010506936CoreglovesCGM-M-00000000001CGM-M-012023-09-06
00860010506943CoreglovesCGM-S-00000000001CGM-S-012023-09-06
00860010506950CoreglovesCGM-XS-00000000001CGM-XS-012023-09-06
00860010506967CoreglovesCGM-LC-XL-00000000001CGM-LC-XL-012023-09-06
00860010506974CoreglovesCGM-LC-L-00000000001CGM-LC-L-012023-09-06
00860010506981CoreglovesCGM-LC-M-00000000001CGM-LC-M-012023-09-06
00860010506998CoreglovesCGM-LC-S-00000000001CGM-LC-S-012023-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840064641262Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
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10840064641286Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641293Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
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10840064641323Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
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00860010400906LuvatekR&C Imports LLCLZA2026-07-29
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