FDA.reportPublic FDA data

Mascon Medical

Primary DI
00850048855403
Brand
Mascon Medical
Company
Mascon, Inc.
Model
MM-GL-N-300-L-3.0M
Catalog number
MM-GL-N-300-L-3.0M
Device description
Powder Free Nitrile Exam Gloves, Blue, Large
Published
2024-04-15
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850048855410PackageGS110In Commercial Distribution
00850048855403PrimaryGS10
10850048855400Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048855410008500488554108500488554100850048855410
00850048855403008500488554038500488554030850048855403
1085004885540010850048855400

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
106772338
Device count
300

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850048855007Mascon MedicalMM-GL-N-100-LMM-GL-N-100-L2023-02-03
00850048855021Mascon MedicalMM-GL-N-100-MMM-GL-N-100-M2023-02-03
00850048855045Mascon MedicalMM-GL-N-100-SMM-GL-N-100-S2023-02-03
00850048855069Mascon MedicalMM-GL-N-100-XLMM-GL-N-100-XL2023-02-03
00850048855083Mascon MedicalMM-GL-N-100-XSMM-GL-N-100-XS2023-02-03
00850048855120Mascon MedicalMM-GL-N-200-LMM-GL-N-200-L2023-02-03
00850048855144Mascon MedicalMM-GL-N-200-MMM-GL-N-200-L2023-02-03
00850048855168Mascon MedicalMM-GL-N-200-SMM-GL-N-200-S2023-02-03
00850048855182Mascon MedicalMM-GL-N-200-XLMM-GL-N-200-XL2023-02-03
00850048855243Mascon MedicalMM-GL-N-300-LMM-GL-N-300-L2023-02-03
00850048855267Mascon MedicalMM-GL-N-300-MMM-GL-N-300-M2023-02-03
00850048855281Mascon MedicalMM-GL-N-300-SMM-GL-N-300-S2023-02-03
00850048855304Mascon MedicalMM-GL-N-250-XLMM-GL-N-250-XL2023-02-03
00850048855328Mascon MedicalMM-GL-N-300-XSMM-GL-N-300-XS2023-02-03
00850048855366Mascon MedicalMM-GL-N-300-S-3.0MMM-GL-N-300-S-3.0M2024-04-15
00850048855380Mascon MedicalMM-GL-N-300-M-3.0MMM-GL-N-300-M-3.0M2024-04-15
00850048855427Mascon MedicalMM-GL-N-250-XL-3.0MMM-GL-N-250-XL-3.0M2024-04-15
10850048855363Mascon MedicalMM-GL-N-300-S-3.0MMM-GL-N-300-S-3.0M2024-04-15
10850048855387Mascon MedicalMM-GL-N-300-M-3.0MMM-GL-N-300-M-3.0M2024-04-15
10850048855400Mascon MedicalMM-GL-N-300-L-3.0MMM-GL-N-300-L-3.0M2024-04-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00199536900226BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900820BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03
10840064641262Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641279Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641286Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641293Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641309Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641316Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641323Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641330Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641347Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641354Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
00199536000018BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZA2026-07-31