FDA.reportPublic FDA data

Elite

Primary DI
00724351996873
Brand
Elite
Company
Austin Pang Gloves Mfg (u.s.a.) Corp.
Model
8723XL
Catalog number
8723XL
Device description
Nitrile Powder Free Examination Glove, Cobalt Blue
Published
2023-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
00724351996835PackageGS110In Commercial Distribution
00724351996873PrimaryGS10
00724351255338Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724351996835007243519968357243519968350724351996835
00724351996873007243519968737243519968730724351996873
00724351255338007243512553387243512553380724351255338

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
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
5627770088sales@jwisafety.com

Regulatory Flags#

DUNS number
072794423
Device count
100
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724351225720Elite8723XS8723XS2023-11-21
00724351225744Elite8723XXL8723XXL2023-11-21
00724351256434Elite8703AS8703AS2023-11-21
00724351256441Elite8703AM8703AM2023-11-21
00724351256458Elite8703AL8703AL2023-11-21
00724351256465Elite8703AXL8703AXL2023-11-21
00724351996880Elite8723L8723L2023-11-21
00724351996897Elite8723M8723M2023-11-21
00724351996903Elite8723S8723S2023-11-21
00671451132284Pasco Wear-A-Day GlovePASCO952XLPASCO952XL2024-10-15
00671451170729Pasco Wear-A-Day GlovePASCO952LPASCO952L2024-10-15
00671451183866Pasco Wear-A-Day GlovePASCO952XLPASCO952XL2024-10-15
00671451183859Pasco Wear-A-Day GlovePASCO952LPASCO952L2024-10-15
00724351122401Elite Protective Extra8720L8720L2024-07-31
00724351122418Elite Protective Extra8720M8720M2024-07-31
00724351122425Elite Protective Extra8720S8720S2024-07-31
00724351122432Elite Protective Extra8720XL8720XL2024-07-31
00724351222408Safety First8773AXS8773AXS2024-07-31
00724351222422Safety First8773AS8773AS2024-07-31
00724351222446Safety First8773AM8773AM2024-07-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03
10840064641262Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641279Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641286Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641293Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
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10840064641347Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641354Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
00199536000018BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000032BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000049BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000056BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
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00366975065520Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065537Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00860010400906LuvatekR&C Imports LLCLZA2026-07-29