FDA.reportPublic FDA data

Riverstone Resources

Primary DI
00850008325175
Brand
Riverstone Resources
Company
TECHNIGLOVE INTERNATIONAL, INC.
Model
RSNE8032
Published
2019-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008325175PackageGS110In Commercial Distribution
00850008325083PrimaryGS10
00850008325250Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008325175008500083251758500083251750850008325175
00850008325083008500083250838500083250830850008325083
00850008325250008500083252508500083252500850008325250

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

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
false

Other Devices From This Company#

Primary DI, Brand, Model table
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
00850008325465Techniglove International STN205P2019-12-27
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
00850008325182Riverstone ResourcesRSNE80332019-05-14

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Primary DI, Brand, Company table
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