FDA.reportPublic FDA data

PREVENTI

Primary DI
00850046528132
Brand
PREVENTI
Company
Rushmedics LLC
Model
PRB2246
Catalog number
PRB2246
Device description
PREVENTI- BIODEGRADABLE POWDER-FREE NITRILE EXAM GLOVES - LARGE
Published
2023-01-12
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
LZCPatient Examination Glove, Specialty
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850046528139PackageGS110In Commercial Distribution
00850046528132PrimaryGS10
30850046528133Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004652813910850046528139
00850046528132008500465281328500465281320850046528132
3085004652813330850046528133

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
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+12252772255Contact@rushmedics.com

Regulatory Flags#

DUNS number
013526370
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850046528101PREVENTIPRB2240PRB22402023-01-12
00850046528118PREVENTIPRB2242PRB22422023-01-12
00850046528125PREVENTIPRB2244PRB22442023-01-12
00850046528149PREVENTIPRB2248PRB22482023-01-12
00850046528002PREVENTIPRB1940PRB19402022-11-12
00850046528019PREVENTIPRB1941PRB19412022-11-12
00850046528026PREVENTIPRB1942PRB19422022-11-12
00850046528033PREVENTIPRB1943PRB19432022-11-12
00850046528040PREVENTIPRB1944PRB19442022-11-12
00850046528057PREVENTIPRN1920PRN19202022-11-12
00850046528064PREVENTIPRN1921PRN19212022-11-12
00850046528071PREVENTIPRN1922PRN19222022-11-12
00850046528088PREVENTIPRN1923PRN19232022-11-12
00850046528095PREVENTIPRN1924PRN19242022-11-12
10850046528009PREVENTIPRB1940PRB19402022-11-12
10850046528016PREVENTIPRB1941PRB19412022-11-12
10850046528023PREVENTIPRB1942PRB19422022-11-12
10850046528030PREVENTIPRB1943PRB19432022-11-12
10850046528047PREVENTIPRB1944PRB19442022-11-12
10850046528054PREVENTIPRN1920PRN19202022-11-12

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