FDA.reportPublic FDA data

School Nurse Supply

Primary DI
00853927007993
Brand
School Nurse Supply
Company
Strong Medical Partners LLC
Model
4002
Catalog number
34101
Device description
Vinyl Exam Gloves, Powder Free, Size Small (S)
Published
2022-05-05
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853927007993PackageGS11000In Commercial Distribution
00853927007986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853927007993008539270079938539270079930853927007993
00853927007986008539270079868539270079860853927007986

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
Special Storage Condition, Specify00Store under cool, dry conditions. Avoid direct sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-485-2737customerservice@schoolnursesupply.com

Regulatory Flags#

DUNS number
062388929
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00850040791174Strong Manufacturers710171012022-08-19
00810757021056Sam Tell Companies75043NG4PFMD-BK2024-01-12
00810757021063Sam Tell Companies75042NG4PFSM-BK2024-01-12
00810757021070Sam Tell Companies75045NG4PFXL-BK2024-01-12
00810757021049Sam Tell Companies75044NG4PFLG-BK2024-01-12
00810757020899Sam Tell Companies75043NG4PFMD-BK2024-01-12
00810757020905Sam Tell Companies75042NG4PFSM-BK2024-01-12
00810757020912Sam Tell Companies75045NG4PFXL-BK2024-01-12
00810131090609Nception71014GN3042023-11-03
00810131090616Nception71012GN3022023-11-03
00810131090623Nception71013GN3032023-11-03
00810131090630Nception71015GN3052023-11-03
00810131090647Nception71044GN4042023-11-03
00810131090654Nception71042GN4022023-11-03
00810131090661Nception71043GN4032023-11-03
00810131090678Nception71045GN4052023-11-03
00810131090685Nception75042GN402B2023-11-03
00810131090692Nception75043GN403B2023-11-03
00810131090708Nception75044GN404B2023-11-03
00810131090715Nception75045GN405B2023-11-03

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