FDA.reportPublic FDA data

Safe .R World

Primary DI
00860008943231
Brand
Safe .R World
Company
Safe.R World Corporation
Model
5.5 g Medium
Catalog number
NGPF55MB509
Device description
Nitrile examination/treatment glove, non-powdered, non-antimicrobial, single use, 100 count
Published
2022-08-09
Public version status
Update
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009074507PackageGS110In Commercial Distribution
00860008943231PrimaryGS10
00860009069923Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009074507008600090745078600090745070860009074507
00860008943231008600089432318600089432310860008943231
00860009069923008600090699238600090699230860009069923

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
Special Storage Condition, Specify00Store in dry ventilated area, avoid direct sunlight, fluorescent lighting, heat and moisture. Do not store above 104 degrees Fahrenheit or 40 degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
603-560-7546Johnette@saferworlds.com

Regulatory Flags#

DUNS number
048020664
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011258421Safe .R World6.2 gram, Small, BlackNGPF62BS12042024-06-24
00860011258445Safe .R World6.2 gram, Med, BlackNGPF62BM12052024-06-24
00860011258438Safe .R World6.2 gram, Small, BlackNGPF62BS12042024-06-24
00860011258452Safe .R World6.2 gram, Med, BlackNGPF62BM12052024-06-24
00860010937570Safe R. WorldNGPF Biodegradable 3.5g 4.0m, SmallNPFBIO2520CS5742023-11-07
00860010239025Safe .R World3.2 SmallNGPF32SBX5002023-04-17
00860009074590Safe .R World5.5 g SmallNGPF55SB5082023-04-12
10860010937577Safe R. World MSDNGPF Biodegradable 3.5g 4.0m, SmallNPFBIO2520CS5742023-11-07
00860008943200Safe .R World3.2 g. MediumNGPF32MBX5012022-08-09
00860008943217Safe .R World3.2 g. LargeNGPF32LBX5022022-08-09
00860008943224Safe .R World3.2 g XLNGPF320BXL7052022-08-09
00860008943248Safe .R World5.5 g LargeNGPF55LB5102022-08-09
00860008943255Safe .R World5.5 g XLNGPF55XLB5112022-08-09
00860009074538Safe .R WorldNGPF 4.1g 3.2m LargeNGPF412L5602023-03-07
00860009074545Safe .R WorldNGPF Biodegradable 3.5g 4.0m XLargeNPFBIO351XL5642023-03-07
00860009074552Safe .R WorldNGPF Biodegradable 3.5g 4.0m LargeNPFBIO351L5632023-03-07
00860009074569Safe .R WorldNGPF Biodegradable 3.5g 4.0m MediumNPFBIO351M5622023-03-07
00860009074576Safe .R WorldNGPF 4.1g 3.2m MNGPF412M5592023-03-07
00860009074583Safe .R WorldNGPF 4.1g 3.2m XLargeNGPF412XL5612023-03-07
00860010239056Safe .R World6.2 gram, X-Large, BlackNGPF62BXL12012023-09-22

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