FDA.reportPublic FDA data

Restaurant Marketplace

Primary DI
10075289131612
Brand
Restaurant Marketplace
Company
Springfield Grocer Company
Model
665396
Device description
Disposable Nitrile Exam Gloves, Powder Free, Black, 4 mil, Large, 100/bx, 10 bxs/cs
Published
2024-06-20
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
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
10075289131612PackageGS110In Commercial Distribution
00075289131615PrimaryGS10
70075289131614Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007528913161210075289131612
00075289131615000752891316150752891316150075289131615
7007528913161470075289131614

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
417-862-0812info@restaurantmarketplace.com

Regulatory Flags#

DUNS number
006968929
Device count
100
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
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
00075289131608Restaurant Marketplace6653952024-06-20
00075289131615Restaurant Marketplace6653962024-06-20
00075289131622Restaurant Marketplace6653976653972024-06-20
00075289131639Restaurant Marketplace6653986653982024-06-20
10075289131605Restaurant Marketplace6653952024-06-20
10075289131629Restaurant Marketplace6653976653972024-06-20
10075289131636Restaurant Marketplace6653986653982024-06-20

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Primary DI, Brand, Company table
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00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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