FDA.reportPublic FDA data

GloveUP®

Primary DI
00649531592167
Brand
GloveUP®
Company
Dash Medical Gloves, Inc.
Model
GUP300L
Device description
Nitrile Exam Glove, Dark Blue, Large
Published
2021-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00649531593164PackageGS110In Commercial Distribution
00649531592167PrimaryGS10
00649531592068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00649531593164006495315931646495315931640649531593164
00649531592167006495315921676495315921670649531592167
00649531592068006495315920686495315920680649531592068

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.

Contacts#

Phone, Email table
PhoneEmail
4142695298Compliancedepartment@dashmedical.com

Regulatory Flags#

DUNS number
194914768
Device count
300
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
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
00649531592112GloveUP®GUP300XS2022-09-22
00649531592129GloveUP®GUP300S2022-09-22
00649531592143GloveUP®GUP300M2022-09-22
00649531592174GloveUP®GUP300XL2022-09-22
00649531596318FLEX300™FLEX300XS2025-10-23
00649531596325FLEX300™FLEX300S2025-10-23
00649531596349FLEX300™FLEX300M2025-10-23
00649531596363FLEX300™FLEX300L2025-10-23
00649531596370FLEX300™FLEX300XL2025-10-23
00649531596387FLEX300™FLEX300XXL2025-10-23
00649531042129Black Maxx® Extreme NitrileBMNE100S2025-09-09
00649531042143Black Maxx® Extreme NitrileBMNE100M2025-09-09
00649531042167Black Maxx® Extreme NitrileBMNE100L2025-09-09
00649531042174Black Maxx® Extreme NitrileBMNE100XL2025-09-09
00649531042181Black Maxx® Extreme NitrileBMNE100XXL2025-09-09
00649531202011Alasta® PROALGA200XS2025-09-09
00649531202028Alasta® PROALGA200S2025-09-09
00649531202042Alasta® PROALGA200M2025-09-09
00649531202066Alasta® PROALGA200L2025-09-09
00649531202073Alasta® PROALGA200XL2025-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160542118HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-28
10809160541722HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541746HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541753HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00755676002529mvetADI MedicalLZA2026-10-23
00755676002550mvetADI MedicalLZA2026-10-23
00755676002581mvetADI MedicalLZA2026-10-23
00755676002611mvetADI MedicalLZA2026-10-23
00755676002765mvetADI MedicalLZA2026-10-23
00755676002796mvetADI MedicalLZA2026-10-23
00755676002826mvetADI MedicalLZA2026-10-23
00755676002857mvetADI MedicalLZA2026-10-23
00755676002994mvetADI MedicalLZA2026-10-23
00755676003021mvetADI MedicalLZA2026-10-23
00755676003052mvetADI MedicalLZA2026-10-23
00755676003083mvetADI MedicalLZA2026-10-23
10809160541470HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
10809160541487HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
10809160541494HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16