FDA.reportPublic FDA data

Safe .R World

Primary DI
00860009069985
Brand
Safe .R World
Company
Safe.R World Corporation
Model
5.5 g Large
Catalog number
NGPF55LB510
Device description
Nitrile examination/treatment glove, non-powdered, non-antimicrobial, single use, 100 count
Published
2022-08-09
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

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
00860009069985PackageGS110In Commercial Distribution
00860008943248PrimaryGS10
00860009069930Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009069985008600090699858600090699850860009069985
00860008943248008600089432488600089432480860008943248
00860009069930008600090699308600090699300860009069930

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
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
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
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
00860009074576Safe .R WorldNGPF 4.1g 3.2m MNGPF412M5592023-03-07
00860009074583Safe .R WorldNGPF 4.1g 3.2m XLargeNGPF412XL5612023-03-07

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