FDA.reportPublic FDA data

Techniglove Internationa

Primary DI
00850008325519
Brand
Techniglove Internationa
Company
TECHNIGLOVE INTERNATIONAL, INC.
Model
STN1604P
Published
2025-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
02085008325513PackageGS14In Commercial Distribution
00850008325519PrimaryGS10
10850008325516Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
02085008325513020850083255132085008325513
00850008325519008500083255198500083255190850008325519
1085000832551610850008325516

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA 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
Radiation Sterilization

Regulatory Flags#

DUNS number
023942142
Device count
200
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008325472Techniglove International STN1600P2025-07-30
00850008325489Techniglove International STN1601P2025-07-30
00850008325496Techniglove International STN1602P2025-07-30
00850008325502Techniglove International STN1603P2025-07-30
00850008325526Techniglove International STN1605P2025-07-30
02085008325476Techniglove International STN1600P2025-07-30
02085008325483Techniglove International STN1601P2025-07-30
02085008325490Techniglove International STN1602P2025-07-30
02085008325506Techniglove International STN1603P2025-07-30
02085008325513Techniglove InternationaSTN1604P2025-07-30
02085008325520Techniglove International STN1605P2025-07-30
10850008325356Techniglove International STN200P2019-12-27
10850008325370Techniglove International STN201P2019-12-27
10850008325394Techniglove International STN202P2019-12-27
10850008325417Techniglove International STN203P2019-12-27
10850008325431Techniglove International STN204P2019-12-27
10850008325455Techniglove International STN205P2019-12-27
00850008325007Techniglove International RV4002019-05-14
00850008325014Techniglove International RV4012019-05-14
00850008325021Techniglove International RV4022019-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
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09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
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09001570557919Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
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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
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12