Milker's Helpers

Primary DI
10850020255129
Brand
Milker's Helpers
Company
SUMMIT GLOVE INC.
Model
71950PF
Device description
5mil, 9.5" in Length, Nitrile, Examination Grade, Micro-textured, Ambidextrous, Single Use, Rolled Cuff, Powder Free, Blue, Size X-Large Sample Pack
Published
2020-08-01
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
10850020255129PackageGS11200In Commercial Distribution
00850020255122PrimaryGS10
00850020255139Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002025512910850020255129
00850020255122008500202551228500202551220850020255122
00850020255139008500202551398500202551390850020255139

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(330)868-0066klynn@summitglove.com

Regulatory Flags#

DUNS number
054386458
Device count
4
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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Primary DI, Brand, Model table
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00150062224248Get-A-GripOPI0811L2024-04-29
00150062224262Get-A-GripOPI0812XL2024-04-29
00150062224286Get-A-GripOPI0813XXL2024-04-29
00150062224309Get-A-GripOPI0814XXXL2024-04-29
00150062224323Get-A-GripOPI0808S2024-04-29
00150062224347Get-A-GripOPI0810M2024-04-29
00150062224361Get-A-GripOPI0811L2024-04-29
00150062224385Get-A-GripOPI0812XL2024-04-29
00150062224408Get-A-GripOPI0813XXL2024-04-29
00150062224422Get-A-GripOPI0814XXXL2024-04-29
00150062224002INTERCEPT FREE91130-EC2024-03-13
00150062224125INTERCEPT FREE911540-EC2024-03-13
00150062224149INTERCEPT FREE91150-EC2024-03-13
00150062224163INTERCEPT FREE91160-EC2024-03-13
00150062224187INTERCEPT FREE91170-EC2024-03-13
00150020255482Intercept Free91120-EC2024-03-11
00150020255505Intercept Free91120-EC2024-03-11
00150062224019Intercept Free91140-EC2024-03-11

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