FDA.reportPublic FDA data

HEPRO.US Nitrile Standard Class Series 400

Primary DI
00850578007860
Brand
HEPRO.US Nitrile Standard Class Series 400
Company
HEPRO.US INC.
Model
BX - 400 Nitrile Small
Device description
Disposable Nitrile Gloves Series 400, Ambidextrous, Color Blue, Size Small 1 Box 100pcsHEPRO.US Nitrile Standard Class Series 400
Published
2017-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850578007860PrimaryGS10
85057800786001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850578007860008505780078608505780078600850578007860
8505780078600185057800786001

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-sterileA non-sterile 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080061451
Device count
100
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854427007056HEPRO.US Standard Surgical Gown CaseCT - Standard Surgical Gown Spunlace2017-06-21
00854427007063HEPRO.US Reinforced Surgical Gown Case 43gsmCT - Reinforced Surgical Gown 43gsm SMMS2017-06-21
00854427007841HEPRO.US Standard Surgical Gown L 43gsm 1 PouchSingle Pouch Standard Surgical gown SMMS2017-06-20
00854427007858HEPRO.US Reinforced Surgical Gown L 43gsm Single Pouch Reinforced Surgical Gown 43gsm SMMS2017-06-20
00854427007964HEPRO.US Standard Surgical Gown 68 gsmSingle Pouch Standard Surgical Gown 68gsm2017-06-20
00854427007971HEPRO.US Reinforced Surgical Gown Single Pouch 68gsmSingle Pouch Reinforced Surgical Gown 68gsm2017-06-20
00850578007174HEPRO.US Disposable Nitrile Gloves Class 450 SmallBX - 450 Nitrile Small 2017-06-21
00850578007181HEPRO.US - Disposable Nitrile Gloves Class 400 SmallCT - 400 Nitrile Small 2017-06-21
00850578007655HEPRO.US Latex Examination Gloves Size MediumCT - Latex Exam Medium 2017-06-21
00850578007662HEPRO.US Case of 10 boxes LARGE Latex Examination GlovesCT - Latex Exam Large2017-06-21
00850578007730HEPRO.US - Latex Examination Gloves SMALL - 100 in one BoxBX Latex Exam Small2017-06-21
00850578007754HEPRO.US – Latex Examination Gloves – 100 per Box - Size MediumBX - Latex Exam Medium 2017-06-21
00850578007761HEPRO.US Latex Examination Gloves Size Large BX - Latex Exam Large 2017-06-21
00850578007785"HEPRO.US Sterile Latex Surgical Gloves 7""""BX Surgical Latex Gloves 7"""2017-06-21
00850578007792"HEPRO.US Sterile Latex Surgical Gloves 7.5""""BX Surgical Latex Gloves 7.5"""2017-06-21
00850578007822HEPRO.US Nitrile Standard Class Series 350BX - 350 Nitrile Small 2017-06-21
00850578007839HEPRO.US Nitrile Standard Class Medium Series 350 BX - 350 Nitrile Medium 2017-06-21
00850578007846HEPRO.US - Nitrile Disposable Gloves Deluxe Class 350 Non-Powdered TexturedBX - 350 Nitrile Large 2017-06-21
00850578007853HEPRO.US Nitrile Standard Class Series 350 - 1 Box 100pcsBX - 350 Nitrile XL2017-06-21
00850578007877HEPRO.US Nitrile Standard Class Series 400 MediumBX - 400 Nitrile Medium 2017-06-21

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