FDA.reportPublic FDA data

Eagle Derma2 Nitrile Examination Gloves

Primary DI
09421024254643
Brand
Eagle Derma2 Nitrile Examination Gloves
Company
Eagle Protect Pbc
Model
M
Catalog number
1152312
Device description
Derma2 Nitrile Examination Gloves, Black, Powder-free, size M
Published
2023-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCPatient Examination Glove, Specialty
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19421024254640PackageGS1100In Commercial Distribution
09421024254643PrimaryGS10
09421024254810Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1942102425464019421024254640
09421024254643094210242546439421024254643
09421024254810094210242548109421024254810

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
800-384-3905info@eagleprotect.com

Regulatory Flags#

DUNS number
080473605
Device count
200
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421024254636Eagle Derma2 Nitrile Examination GlovesS11522122023-01-02
09421024254650Eagle Derma2 Nitrile Examination GlovesL11524122023-01-02
09421024254667Eagle Derma2 Nitrile Examination GlovesXL11525122023-01-02
09421024254674Eagle Derma2 Nitrile Examination Gloves2XL11526122023-01-02
19421024254633Eagle Derma2 Nitrile Examination GlovesS11522122023-01-02
19421024254640Eagle Derma2 Nitrile Examination GlovesM11523122023-01-02
19421024254657Eagle Derma2 Nitrile Examination GlovesL11524122023-01-02
19421024254664Eagle Derma2 Nitrile Examination GlovesXL11525122023-01-02
19421024254671Eagle Derma2 Nitrile Examination Gloves2XL11526122023-01-02
09421024254681Eagle Derma2 Nitrile Examination GlovesXS11521122023-01-02
09421024252823Eagle Sensitive Nitrile Examination GlovesS11612122022-12-07
09421024252830Eagle Sensitive Nitrile Examination GlovesM11613122022-12-07
09421024252847Eagle Sensitive Nitrile Examination GlovesL11614122022-12-07
09421024252854Eagle Sensitive Nitrile Examination GlovesXL11615122022-12-07
09421024252922Eagle Sensitive Nitrile Examination Gloves2XL11616122022-12-12
09421024254124Eagle Derma2 Nitrile Examination GlovesS11512122022-12-07
09421024254131Eagle Derma2 Nitrile Examination GlovesM11513122022-12-07
09421024254148Eagle Derma2 Nitrile Examination GlovesL11514122022-12-07
09421024254155Eagle Derma2 Nitrile Examination GlovesXL11515122022-12-07
09421024254162Eagle Derma2 Nitrile Examination GlovesXS11511122022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09001570557278Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
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
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570536686Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536693Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536709Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536716Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536723Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536730Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536747Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536754Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
08994452290022Nitrile Examination Gloves Powder FreePT. SINTONG UNIGOLDEN GLOVELZA2024-02-26
08994452290022Nitrile Examination Gloves Powder FreePT. SINTONG UNIGOLDEN GLOVELZC2024-02-26