FDA.reportPublic FDA data

Dyna Plus Nitrile Examination Gloves, Blue - Powder-Free, X-Small

Primary DI
00616784251530
Brand
Dyna Plus Nitrile Examination Gloves, Blue - Powder-Free, X-Small
Company
DYNAREX CORPORATION
Model
2515
Device description
Ambidextrous
Published
2023-12-21
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
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784251530PackageGS110In Commercial Distribution
00616784251523PrimaryGS10
00616784251516Unit of UseGS10
00810180843713Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784251530006167842515306167842515300616784251530
00616784251523006167842515236167842515230616784251523
00616784251516006167842515166167842515160616784251516
00810180843713008101808437138101808437130810180843713

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

Regulatory Flags#

DUNS number
008124539
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810094577971CuraplexBOUND TREE MEDICAL, LLCQDO2025-03-31
20850061371021American Health and SafetyLabsource, Inc.QDO2025-03-27
20850061371038American Health and SafetyLabsource, Inc.QDO2025-03-27
00850020922413American Health and SafetyLabsource, Inc.QDO2024-12-13
20850020922424American Health and SafetyLabsource, Inc.QDO2024-12-13
20850020922431American Health and SafetyLabsource, Inc.QDO2024-12-13
00850020922444American Health and SafetyLabsource, Inc.QDO2024-12-13
20850020922455American Health and SafetyLabsource, Inc.QDO2024-12-13
00850020922994American Health and SafetyLabsource, Inc.QDO2024-12-13
20850045437477VirtueNephron Nitrile LLCQDO2024-12-02
00810094577797Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00810094577803Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00810094577827Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00810094577841Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00810094577858Curaplex®BOUND TREE MEDICAL, LLCQDO2024-11-30
00304040186619Henry ScheinHENRY SCHEIN, INC.QDO2024-10-11
00304040186633Henry ScheinHENRY SCHEIN, INC.QDO2024-10-11
10810132043373HCSConcordance Healthcare Solutions LLCQDO2024-09-27
00841277108330Sample Pack Velvet Nitrile Exam GloveSEMPERMED USA, INC.QDO2024-09-24
20860011916691DERMADELMedzah IndustriesQDO2024-07-22
20860011917407DERMADELMedzah IndustriesQDO2024-07-22
20850045437941Nephron NitrileNephron Nitrile LLCQDO2024-04-26
10810132043045HCSConcordance Healthcare Solutions LLCQDO2024-04-15
10810132043052HCSConcordance Healthcare Solutions LLCQDO2024-04-15
10810132043069HCSConcordance Healthcare Solutions LLCQDO2024-04-15
10810132043076HCSConcordance Healthcare Solutions LLCQDO2024-04-15
00304040179017Henry ScheinHENRY SCHEIN, INC.QDO2024-03-25