FDA.reportPublic FDA data

Safe R. World MSD

Primary DI
10860010937577
Brand
Safe R. World MSD
Company
Safe.R World Corporation
Model
NGPF Biodegradable 3.5g 4.0m, Small
Catalog number
NPFBIO2520CS574
Device description
Nitrile Powder Free Biodegradable 3.5g, 4.0m, Small, Box of 200
Published
2023-11-07
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
00860010937587PackageGS110In Commercial Distribution
00860010937570PrimaryGS10
10860010937577Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010937587008600109375878600109375870860010937587
00860010937570008600109375708600109375700860010937570
1086001093757710860010937577

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-603-560-7546Johnette@saferworlds.com

Regulatory Flags#

DUNS number
048020664
Device count
200
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00860008943200Safe .R World3.2 g. MediumNGPF32MBX5012022-08-09
00860008943217Safe .R World3.2 g. LargeNGPF32LBX5022022-08-09
00860008943224Safe .R World3.2 g XLNGPF320BXL7052022-08-09
00860008943231Safe .R World5.5 g MediumNGPF55MB5092022-08-09
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
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00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
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10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
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00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
00810145952122NeuleafMedgluv Inc.LZA2026-06-30
00810145952139NeuleafMedgluv Inc.LZA2026-06-30
00810145952146NeuleafMedgluv Inc.LZA2026-06-30
00810145952108NeuleafMedgluv Inc.LZA2026-06-29