FDA.reportPublic FDA data

Advance Plus ™ Nitrile Exam Gloves, Powder-Free

Primary DI
20810012650223
Brand
Advance Plus ™ Nitrile Exam Gloves, Powder-Free
Company
SOUTHERN ANESTHESIA & SURGICAL, INC.
Model
ADV2325
Device description
Nitrile Exam Gloves, Powder-Free, Small, BOX
Published
2020-06-04
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
20810012650223PackageGS110In Commercial Distribution
10810012650226PrimaryGS10
00810012650229Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081001265022320810012650223
1081001265022610810012650226
00810012650229008100126502298100126502290810012650229

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-sterileA non-sterile 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 cool, dry place. Avoid excessive heat. Open box should be shielded from exposure to direct sun or fluorescent lighting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119186732
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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
10810012650172Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23202020-05-28
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
20810012650230Advance Plus ™ Nitrile Exam Gloves, Powder-FreeADV23262020-06-04

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Primary DI, Brand, Company table
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00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
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10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
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10840330702239ProCureTwin Med, LLCLZA2026-06-01