FDA.reportPublic FDA data

CITATION

Primary DI
00850082546312
Brand
CITATION
Company
Seattle Glove, Inc.
Model
V908MPF-M
Device description
HIGH RISK NITRILE POWDER FREE MEDICAL EXAM GLOVES, 50/BOX, LONG CUFF, M, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL RESISTANT
Published
2025-12-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00850082546497PackageGS11In Commercial Distribution
00850082546312PrimaryGS10
00850082546138Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850082546497008500825464978500825464970850082546497
00850082546312008500825463128500825463120850082546312
00850082546138008500825461388500825461380850082546138

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.

Regulatory Flags#

DUNS number
878594456
Device count
10
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850082546176CITATIONV900MPF-XS2025-12-26
00850082546183CITATIONV900MPF-S2025-12-26
00850082546213CITATIONV900MPF-XL2025-12-26
00850082546220CITATIONV900MPF-XXL2025-12-26
00850082546237CITATIONV905MPF-XS2025-12-26
00850082546244CITATIONV905MPF-S2025-12-26
00850082546251CITATIONV905MPF-M2025-12-26
00850082546268CITATIONV905MPF-L2025-12-26
00850082546275CITATIONV905MPF-XL2025-12-26
00850082546282CITATIONV905MPF-XXL2025-12-26
00850082546299CITATIONV908MPF-XS2025-12-26
00850082546305CITATIONV908MPF-S2025-12-26
00850082546329CITATIONV908MPF-L2025-12-26
00850082546336CITATIONV908MPF-XL2025-12-26
00850082546343CITATIONV908MPF-XXL2025-12-26
00850082546541CITATIONV900MPF-L2025-12-26
00850082546350CITATIONV900MPF-XS2025-12-26
00850082546367CITATIONV900MPF-S2025-12-26
00850082546398CITATIONV900MPF-XL2025-12-26
00850082546404CITATIONV900MPF-XXL2025-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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.LZC2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZC2026-06-04
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01