FDA.reportPublic FDA data

CITATION

Primary DI
00850082546305
Brand
CITATION
Company
Seattle Glove, Inc.
Model
V908MPF-S
Device description
HIGH RISK NITRILE POWDER FREE MEDICAL EXAM GLOVES, 500/CS, LONG CUFF, S, 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
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850082546480PackageGS11In Commercial Distribution
00850082546305PrimaryGS10
00850082546121Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850082546480008500825464808500825464800850082546480
00850082546305008500825463058500825463050850082546305
00850082546121008500825461218500825461210850082546121

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
00850082546312CITATIONV908MPF-M2025-12-26
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
00850054870544BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870551BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870568BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870582BAYLAB USABaylab USA, LLCLZA2026-10-01
00662956201063Body Guard[Fastenal CompanyLZA2026-09-30
00662956201285Body Guard[Fastenal CompanyLZA2026-09-30
00662956202558Body GuardFastenal CompanyLZA2026-09-30
00662956203258Body GuardFastenal CompanyLZA2026-09-30
00662956203661BodyguardFastenal CompanyLZA2026-09-30
00662956203760BodyguardFastenal CompanyLZA2026-09-30
00662956205320Body GuardFastenal CompanyLZA2026-09-30
00662956210171Body GuardFastenal CompanyLZA2026-09-30
10860015093766MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093773MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093780MaadhoMaadho Distributors Inc.LZA2026-09-24
00199536900219BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900219BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900820BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900820BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZC2026-08-14