FDA.reportPublic FDA data

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

Primary DI
00048329000455
Brand
M.C. JOHNSON NITRILE EXAM GLOVE - SMALL (100ct)
Company
M.C. JOHNSON CO., INC.
Model
GNCFS
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
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
00048329000455PackageGS1100In Commercial Distribution
00048329000462PackageGS110In Commercial Distribution
00048329000448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00048329000455000483290004550483290004550048329000455
00048329000462000483290004620483290004620048329000462
00048329000448000483290004480483290004480048329000448

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
239.433.1538charlis@mcjohnson.com

Regulatory Flags#

DUNS number
112853395
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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
00048329000530M.C. JOHNSON NITRILE EXAM GLOVE X-LARGE (100ct)GNCFXL2023-06-09
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
00048329000486M.C. JOHNSON NITRILE EXAM GLOVE - MEDIUM (100ct)GNCFM2023-06-09

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05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
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00850005229841NeulynxMedgluv Inc.LZA2026-07-17
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10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
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