FDA.reportPublic FDA data

SafeHealth

Primary DI
04712832889895
Brand
SafeHealth
Company
PM GLOVES U S A INC
Model
GNFB14134
Device description
Nitrile Gloves, PF, Cobalt Blue F L
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

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
K171422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171422000Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink ColorEver Global (Vietnam) Enterprise Corp2018-06-11LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04712832889932PackageGS11000In Commercial Distribution
04712832889895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712832889932047128328899324712832889932
04712832889895047128328898954712832889895

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

Contacts#

Phone, Email table
PhoneEmail
+1(909) 4659188xxx@xx.xx

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
04712832884265SafeHealthGNFB241722022-11-02
04712832884272SafeHealthGNFB241732022-11-02
04712832884289SafeHealthGNFB241742022-11-02
04712832884296SafeHealthGNFB241752022-11-02
04712832886726SafeHealthGVFB210022022-11-02

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Primary DI, Brand, Company table
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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
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