FDA.reportPublic FDA data

Hand Armor

Primary DI
10787081126856
Brand
Hand Armor
Company
TRANZONIC ACQUISITION CORP.
Model
GDNPF105X
Catalog number
GDNPF105X
Device description
NITRILE POWDER FREE EXAM GLOVES BLACK 6 MIL 10/100-EX-LARGE
Published
2020-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
K151528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151528000Powder Free Nitrile (Black) Examination GlovesGallant Quality Sdn. Bhd.2015-10-09LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10787081126856PackageGS110In Commercial Distribution
00787081126859PrimaryGS10
70787081126858Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1078708112685610787081126856
00787081126859007870811268597870811268590787081126859
7078708112685870787081126858

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

Contacts#

Phone, Email table
PhoneEmail
8003219832info@hospeco.com

Regulatory Flags#

DUNS number
090125555
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00075289122392OPTIFY GL-NCF265BFXS GL-NCF265BFXS 2020-04-20
00075289122408OPTIFY GL-NCF265BFS GL-NCF265BFS 2020-04-20
00075289122415OPTIFY GL-NCF265BFM GL-NCF265BFM 2020-04-20
00075289122422OPTIFY GL-NCF265BFL GL-NCF265BFL 2020-04-20
00075289122439OPTIFY GL-NCF265BFX GL-NCF265BFX 2020-04-20
00075289122446KODA GL-NCF235BKFXS GL-NCF235BKFXS 2020-04-20
00075289122453KODA GL-NCF235BKFS GL-NCF235BKFS 2020-04-20
00075289122460KODA GL-NCF235BKFM GL-NCF235BKFM 2020-04-20
00075289122477KODA GL-NCF235BKFL GL-NCF235BKFL 2020-04-20
00075289122484KODA GL-NCF235BKFX GL-NCF235BKFX 2020-04-20
00075289122491Enov-8 GL-NCF225BFXS GL-NCF225BFXS 2020-04-27
00075289122507Enov-8 GL-NCF225BFS GL-NCF225BFS 2020-04-20
00075289122514Enov-8 GL-NCF225BFM GL-NCF225BFM 2020-04-20
00075289122521Enov-8 GL-NCF225BFL GL-NCF225BFL 2020-04-20
00075289122538Enov-8 GL-NCF225BFX GL-NCF225BFX 2020-04-20
00075289122545OPTIFY GL-NCF265BFXX GL-NCF265BFXX 2020-04-20
00075289122552KODA GL-NCF235BKFXX GL-NCF235BKFXX 2020-04-20
00075289127328ProWorksGL-N108EPF-SMGL-N108EPF-SM2020-04-20
00075289127335ProWorksGL-N108EPF-MEDGL-N108EPF-MED2020-04-20
00075289127342ProWorksGL-N108EPF-LGGL-N108EPF-LG2020-04-20

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