FDA.reportPublic FDA data

PremierPro Surgeons Glove

Primary DI
00811220030537
Brand
PremierPro Surgeons Glove
Company
PRESTIGE AMERITECH, LTD.
Model
43285
Catalog number
43285
Device description
Pair of Sterile Polyisoprene Glovessixe 8.5Color Green
Published
2019-01-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
10811220030534PackageGS150In Commercial Distribution
20811220030531PackageGS14In Commercial Distribution
00811220030537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081122003053410811220030534
2081122003053120811220030531
00811220030537008112200305378112200305370811220030537

GMDN Terms#

Term, Definition table
TermDefinition
Polyisoprene surgical glove, non-powdered, antimicrobialA device made of polyisoprene intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; it includes an antimicrobial or antiviral agent/properties to reduce viable-microbe exposure in case of sharp penetration and its inner surface is not covered with powder. It is used mainly as a two-way barrier to protect patient and staff from 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, elasticity) and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-855-531-7699info@s2s-global.com

Regulatory Flags#

DUNS number
199692794
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811220035433PremierProD5061D50612024-03-08
00811220035440PremierProD5062D50622024-03-08
00811220035457PremierProD5063D50632024-03-08
00811220035464PremierProD5064D50642024-03-08
00811220035471PremierProD5065D50652024-03-08
00852212003269ProKidsFM85030-CCM12016-09-26
00852212003344ProGearFM85011-CCM12016-09-26
00852212003214ProKidsFM850302016-09-26
00852212003801ProGear7410E32026-04-21
00852212003788PrestigePro24512026-03-27
00852212003795PrestigePro24532026-03-27
00818566016454PremierPro24512016-07-15
00818566019783PremierPro24532020-04-28
20818566017479PremierPro531153112020-07-15
20818566017486PremierPro531253122020-07-15
00811220030001PremierPro6604PP6604PP2020-09-08
00811220030018PremierPro6605PP6605PP2020-09-08
00811220030032PremierPro24922020-04-28
00811220030049PremierPro881788172020-08-29
00811220030056PremierPro881888182020-08-29

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