FDA.reportPublic FDA data

SafeHealth

Primary DI
04712832889901
Brand
SafeHealth
Company
PM GLOVES U S A INC
Model
GNFB14135
Device description
Nitrile Gloves, PF, Cobalt Blue F XL
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
04712832889949PackageGS11000In Commercial Distribution
04712832889901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712832889949047128328899494712832889949
04712832889901047128328899014712832889901

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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