FDA.reportPublic FDA data

Safe .R World

Primary DI
00860009074576
Brand
Safe .R World
Company
Safe.R World Corporation
Model
NGPF 4.1g 3.2m M
Catalog number
NGPF412M559
Device description
Nitrile Powder Free Examination Single Use Glove 4.1g 3.2m Medium, Box of 200
Published
2023-03-07
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071910000NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)Hartalega Sdn Bhd2007-09-06LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009074576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009074576008600090745768600090745760860009074576

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
603-560-7546Johnette@saferworlds.com

Regulatory Flags#

DUNS number
048020664
Device count
1
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
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
00860009074583Safe .R WorldNGPF 4.1g 3.2m XLargeNGPF412XL5612023-03-07
00860010239056Safe .R World6.2 gram, X-Large, BlackNGPF62BXL12012023-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
D184MYNTGNLG100BLK14MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100PNK1MYNTMynt ProfessionalLZA2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15