FDA.report

Techniglove International

Primary DI
00850008325465
Brand
Techniglove International
Company
TECHNIGLOVE INTERNATIONAL, INC.
Model
STN205P
Published
2019-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LZCPatient Examination Glove, Specialty

Product Code Classifications

CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850008325465PackageGS14In Commercial Distribution
10850008325455PrimaryGS10
00850008325458Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008325465008500083254658500083254650850008325465
1085000832545510850008325455
00850008325458008500083254588500083254580850008325458

GMDN Terms

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
Radiation Sterilization

Regulatory Flags

DUNS number
023942142
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00850008325366Techniglove International STN200P2019-12-27
00850008325380Techniglove International STN201P2019-12-27
00850008325403Techniglove International STN202P2019-12-27
00850008325427Techniglove International STN203P2019-12-27
00850008325441Techniglove International STN204P2019-12-27
00850008325113Techniglove International RV4002019-05-14
00850008325342Techniglove International RV4012019-05-14
00850008325120Techniglove International RV4022019-05-14
00850008325137Techniglove International RV4032019-05-14
00850008325144Techniglove International RV4042019-05-14
00850008325151Techniglove International RV4052019-05-14
00850008325168Riverstone ResourcesRSNE80312019-05-14
00850008325175Riverstone ResourcesRSNE80322019-05-14
00850008325182Riverstone ResourcesRSNE80332019-05-14

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