FDA.reportPublic FDA data

Elite

Primary DI
00724351225751
Brand
Elite
Company
Austin Pang Gloves Mfg (u.s.a.) Corp.
Model
8723XXL
Catalog number
8723XXL
Device description
Nitrile Powder Free Examination Glove, Cobalt Blue
Published
2023-11-21
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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141304000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141304000YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLORYongxin Healthcare Co., Ltd.2014-12-12LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724351225751PackageGS110In Commercial Distribution
00724351225744PrimaryGS10
00724351255345Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724351225751007243512257517243512257510724351225751
00724351225744007243512257447243512257440724351225744
00724351255345007243512553457243512553450724351255345

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5627770088sales@jwisafety.com

Regulatory Flags#

DUNS number
072794423
Device count
100
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00724351996873Elite8723XL8723XL2023-11-21
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

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