FDA.reportPublic FDA data

Advance Plus ™ Nitrile Exam Gloves, Powder-Free

Primary DI
10810012650172
Brand
Advance Plus ™ Nitrile Exam Gloves, Powder-Free
Company
SOUTHERN ANESTHESIA & SURGICAL, INC.
Model
ADV2320
Device description
Nitrile Exam Gloves, Powder-Free, Small, BOX
Published
2020-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
20810012650179PackageGS110In Commercial Distribution
10810012650172PrimaryGS10
00810012650175Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081001265017920810012650179
1081001265017210810012650172
00810012650175008100126501758100126501750810012650175

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, ventilated area. Avoid direct sunlight, heat & moisture. Do not store above 100°F (38°C)

Regulatory Flags#

DUNS number
119186732
Device count
100
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
00810012650083Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23292020-05-28
00810012650090Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23302020-05-28
00810012650106Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23312020-05-28
00810012650113Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23322020-05-28
00810012650120Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23292020-05-28
00810012650137Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23302020-05-28
00810012650144Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23312020-05-28
00810012650151Advance Plus ™ Latex Exam Gloves, Powder-FreeADV23322020-05-28
10810012650165Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23192020-05-28
10810012650189Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23212020-05-28
10810012650196Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23222020-05-28
10810012650202Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23232020-05-28
10810012650219Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23242020-06-04
10810012650226Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23252020-06-04
10810012650233Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23262020-06-04
10810012650240Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23272020-06-04
10810012650257Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23282020-06-04
20810012650216Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23242020-06-04
20810012650223Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23252020-06-04
20810012650230Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23262020-06-04

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05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
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00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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