FDA.reportPublic FDA data

Elite High Risk

Primary DI
00724351255086
Brand
Elite High Risk
Company
Austin Pang Gloves Mfg (u.s.a.) Corp.
Model
84015L
Catalog number
84015L
Device description
Latex Powder Free High Risk Examination Glove, 13 mil, Blue
Published
2023-11-27
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
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724351259541PackageGS110In Commercial Distribution
00724351259534PrimaryGS10
00724351255086Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724351259541007243512595417243512595410724351259541
00724351259534007243512595347243512595340724351259534
00724351255086007243512550867243512550860724351255086

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5627770088sales@jwisafety.com

Regulatory Flags#

DUNS number
072794423
Device count
50
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
true
No natural rubber latex
false
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZC2026-06-04
09001570557278Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557940Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557971Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570558008Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557377Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12