FDA.reportPublic FDA data

Safe .R World

Primary DI
00860011258438
Brand
Safe .R World
Company
Safe.R World Corporation
Model
6.2 gram, Small, Black
Catalog number
NGPF62BS1204
Device description
Nitrile Powder Free Examination Glove, Single Use, 6.2 gram, Small, Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
Published
2024-06-24
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
00860011258438PackageGS110In Commercial Distribution
00860011258421PrimaryGS10
10860011258428Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011258438008600112584388600112584380860011258438
00860011258421008600112584218600112584210860011258421
1086001125842810860011258428

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@bluechiphygiene.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
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
00860010239056Safe .R World6.2 gram, X-Large, BlackNGPF62BXL12012023-09-22

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