FDA.reportPublic FDA data

Norco Nitrile Gloves

Primary DI
00768627017312
Brand
Norco Nitrile Gloves
Company
NORTH COAST MEDICAL, INC.
Model
4594
Catalog number
NC20545-4
Device description
Norco Nitrile Gloves, Blue X-Large (100)
Published
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
00768627017312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00768627017312007686270173127686270173120768627017312

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Regulatory Flags#

DUNS number
060121928
Device count
1
DM exempt
false
Premarket exempt
false
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
00768627017145Blue Diamond 360 Needle Stimulator4581NCBD-3602026-06-01
00768627017152Blue Diamond 360 Needle Stimulator Lead Wires - Alligator Clip4581NCBD-360-012026-06-01
00768627017169Blue Diamond 360 Needle Stimulator Lead Wires - Pigtail4581NCBD-360-022026-06-01
00768627017275Norco Sharps Container4595NC229412026-06-01
00768627017282Norco Nitrile Gloves4594NC20545-12026-06-01
00768627017299Norco Nitrile Gloves4594NC20545-122026-06-01
00768627017305Norco Nitrile Gloves4594NC20545-32026-06-01
10768627016497Push Patch Controlled Released 12.04549NC881912025-12-01
00768627016995PushPatch Delicate (6)4549NC881922025-12-01
00768627016988PushPatch Delicate (6)4549NC881922025-12-01
20768627016494Push Patch Controlled Released 12.04549NC881912025-12-01
10768627016299ActivaTek Ionto4 KitNC8937645112025-04-02
10768627016305ActivaTek Ionto4 KitNC8937745112025-04-02
10768627016312ActivaTek Ionto4 ButterflyNC8937845112025-04-02
10768627016282ActivaTek Ionto4 KitNC8937545112025-04-02
20768627016296ActivaTek Ionto4 KitNC8937645112025-04-02
20768627016302ActivaTek Ionto4 KitNC8937745112025-04-02
20768627016319ActivaTek Ionto4 ButterflyNC8937845112025-04-02
00768627001632NorcoNC8948141232025-03-26
00768627160285Blue DiamondNCBD-161343082023-09-01

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