FDA.reportPublic FDA data

M.C. JOHNSON NITRILE EXAM GLOVE X-LARGE (100ct)

Primary DI
00048329000530
Brand
M.C. JOHNSON NITRILE EXAM GLOVE X-LARGE (100ct)
Company
M.C. JOHNSON CO., INC.
Model
GNCFXL
Device description
CHEMO RATED, FENTANYL RATED, POWDER FREE NITRILE EXAMINATION GLOVE AMBIDEXTROUS, TEXTURED FINGERTIPS, NOT MADE WITH NATURAL RUBBER LATEX, NON-STERILE
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00048329000547PackageGS1100In Commercial Distribution
00048329000554PackageGS110In Commercial Distribution
00048329000530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00048329000547000483290005470483290005470048329000547
00048329000554000483290005540483290005540048329000554
00048329000530000483290005300483290005300048329000530

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
239.433.1538charlis@mcjohnson.com

Regulatory Flags#

DUNS number
112853395
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00048329000028CATH-SECURE PLUS with Skin Barrier Wipe54456P2021-01-06
00048329000035CATH-SECURE for Kids7334-22021-06-09
00048329000158CATH-SECURE Advanced54456ADV2021-06-09
00048329000196CATH-SECURE LOCK5445-12023-06-08
00048329000226CATH-SECURE5445-22019-10-01
00048329000233CATH-SECURE DUAL TAB5445-42020-01-02
00048329000240CATH-SECURE5445-32019-10-15
00048329000257CATH-SECURE PLUS5445-62019-10-15
00048329000417M.C. JOHNSON NITRILE EXAM GLOVE X-SMALL (100ct)GNCFXS2023-06-09
00048329000448M.C. JOHNSON NITRILE EXAM GLOVE - SMALL (100ct)GNCFS2023-06-09
00048329000479M.C. JOHNSON NITRILE EXAM GLOVE - MEDIUM (100ct)GNCFM2023-06-09
00048329000509M.C. JOHNSON NITRILE EXAM GLOVE - LARGE (100ct)GNCFL2023-06-09
00048329000738M.C. JOHNSON NITRILE EXAM GLOVE - X SMALL (250ct)GNCFXS2502023-06-09
00048329000745M.C. JOHNSON NITRILE EXAM GLOVE - SMALL (250ct)GNCFS2502023-06-09
00048329000752M.C. JOHNSON NITRILE EXAM GLOVE - MEDIUM (250ct)GNCFM2502023-06-09
00048329000769M.C. JOHNSON NITRILE EXAM GLOVE - LARGE (250ct)GNCFL2502023-06-09
00048329000776M.C. JOHNSON NITRILE EXAM GLOVE X-LARGE (250ct)GNCFXL2502023-06-09
00048329000424M.C. JOHNSON NITRILE EXAM GLOVE X-SMALL (100ct)GNCFXS2023-06-09
00048329000455M.C. JOHNSON NITRILE EXAM GLOVE - SMALL (100ct)GNCFS2023-06-09
00048329000486M.C. JOHNSON NITRILE EXAM GLOVE - MEDIUM (100ct)GNCFM2023-06-09

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