FDA.reportPublic FDA data

SafeHealth

Primary DI
04712832884265
Brand
SafeHealth
Company
PM GLOVES U S A INC
Model
GNFB24172
Device description
Nitrile Gloves, PF, RoyalBlue F CHEMO I S
Published
2022-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04712832884319PackageGS11000In Commercial Distribution
04712832884265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712832884319047128328843194712832884319
04712832884265047128328842654712832884265

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
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
361339419
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04712832882438SafeHealthGVFB010122022-11-03
04712832882445SafeHealthGVFB010132022-11-03
04712832882452SafeHealthGVFB010142022-11-03
04712832882469SafeHealthGVFB010152022-11-03
04712832882483SafeHealthGVFB010122022-11-03
04712832882490SafeHealthGVFB010132022-11-03
04712832882506SafeHealthGVFB010142022-11-03
04712832882513SafeHealthGVFB010152022-11-03
04712832881929SafeHealthGNFB241542022-11-02
04712832881936SafeHealthGNFB241552022-11-02
04712832882537SafeHealthGVFB270322022-11-02
04712832882544SafeHealthGVFB270332022-11-02
04712832882551SafeHealthGVFB270342022-11-02
04712832882568SafeHealthGVFB270352022-11-02
04712832884258SafeHealthGNFB241712022-11-02
04712832884272SafeHealthGNFB241732022-11-02
04712832884289SafeHealthGNFB241742022-11-02
04712832884296SafeHealthGNFB241752022-11-02
04712832886726SafeHealthGVFB210022022-11-02
04712832886733SafeHealthGVFB210032022-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
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, LLCLZC2026-10-15
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15