FDA.reportPublic FDA data

"HEPRO.US Sterile Latex Surgical Gloves 1 Box 50 pairs-Size Large 8"""

Primary DI
00854427007193
Brand
"HEPRO.US Sterile Latex Surgical Gloves 1 Box 50 pairs-Size Large 8"""
Company
HEPRO.US INC.
Model
BX Surgical Latex Glove
Device description
"HEPRO.US Sterile Latex Surgical Gloves 1 Box 50 pairs-Size Large 8""Surgical Gloves-Non-powder Sterilized by Gamma Radiation, Sterile Until package is opened 8"""
Published
2017-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854427007193PrimaryGS10
85442700719301Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854427007193008544270071938544270071930854427007193
8544270071930185442700719301

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powderedA sterile device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder and it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080061451
Device count
50
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
00850578007860HEPRO.US Nitrile Standard Class Series 400BX - 400 Nitrile Small 2017-06-21

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