Bulk Pax

Primary DI
00037182133479
Brand
Bulk Pax
Company
Bulk Pax
Model
HEAT-M
Device description
Powder-free Exam Grade Black Nitrile Glove - Size Medium
Published
2023-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K133307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133307000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00037182133523PackageGS110In Commercial Distribution
00037182133479PrimaryGS10
00793945409020Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00037182133523000371821335230371821335230037182133523
00037182133479000371821334790371821334790037182133479
00793945409020007939454090207939454090200793945409020

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.

Regulatory Flags#

DUNS number
132477840
Device count
100
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00037182133486Bulk PaxHEAT-LG2023-02-16
00037182133493Bulk PaxHEAT-XL2023-02-16
00037182133462Bulk PaxHEAT-S2023-02-16
00037182133523Bulk PaxHEAT-M2023-02-16
00037182133530Bulk PaxHEAT-LG2023-02-16
00037182133547Bulk PaxHEAT-XL2023-02-16

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Primary DI, Brand, Company table
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