FDA.reportPublic FDA data

ProWorks

Primary DI
10075289145145
Brand
ProWorks
Company
TRANZONIC ACQUISITION CORP.
Model
GL-N135FX
Catalog number
GL-N135FX
Device description
ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 4 mil, X-Large, 100/bx, 10 bxs/cs
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
K081592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081592000POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVESQuality Gallant Sdn. Bhd.2008-12-03LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10075289145145PackageGS110In Commercial Distribution
00075289145148PrimaryGS10
70075289145147Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007528914514510075289145145
00075289145148000752891451480752891451480075289145148
7007528914514770075289145147

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202196mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202202mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202219mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209249Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209256Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209263Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209270Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209287Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209294Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209300Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209317Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209324Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209331Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
09551006060525NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060532NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060549NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060556NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060563NITRILECARE PREMIUMCAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060624NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060631NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060648NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060655NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060662NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060822NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061225NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061249CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061256CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061263CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08