FDA.reportPublic FDA data

OmniTrustTM

Primary DI
50810572003843
Brand
OmniTrustTM
Company
OMNI INTERNATIONAL CORP.
Model
216-22
Catalog number
216-22
Device description
Nitrile Examination Glove Powder Free Medium
Published
2020-12-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810572003843PackageGS110In Commercial Distribution
00810572003848PrimaryGS10
10810572003845Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081057200384350810572003843
00810572003848008105720038488105720038480810572003848
1081057200384510810572003845

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
16034711499Info@Omnigloves.com

Regulatory Flags#

DUNS number
079434709
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50810572000095OmniTrustTM50325-1950325-192020-12-11
00810572000045OmniTrustTM80250-2980250-292020-12-16
00810572000397OmniTrustTM9112-319112-312020-12-10
00810572000434OmniTrust201-225201-2252025-01-31
00810572000861OmniTrustTM313-11313-112019-09-06
00810572000878OmniTrustTM313-12313-122019-08-27
00810572000885OmniTrustTM313-13313-132019-08-27
00810572000892OmniTrustTM313-14313-142019-08-27
00810572001127OmniTrustTM113-01113-012019-08-27
00810572001134OmniTrustTM113-02113-022019-08-27
00810572001141OmniTrustTM113-03113-032019-08-27
00810572001158OmniTrustTM113-04113-042019-08-27
00810572001165OmniTrustTM212-20212-202019-08-27
00810572001172OmniTrustTM212-21212-212019-08-27
00810572001189OmniTrustTM212-22212-222019-08-27
00810572001196OmniTrustTM212-23212-232019-08-27
00810572001202OmniTrustTM212-24212-242019-08-27
00810572001271OmniTrustTM312-11312-112019-08-27
00810572001288OmniTrustTM312-12312-122019-08-27
00810572001295OmniTrustTM312-13312-132019-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20680651502388HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502395HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502401HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502418HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502425HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651489535HalyardO&M HALYARD, INC.OPJ2026-03-12
10857420007600EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007617EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007624EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007631EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007648EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10813172025477NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025484NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025491NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025507NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025514NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025422NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025439NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025446NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025453NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025460NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10076490788657MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10076490788664MICROFLEX Ansell Healthcare ProductOPJ2025-08-05
10076490788671MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10076490788688MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10076490788695MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10860011343872BIONEXMedzah IndustriesOPJ2025-07-30
10860011343889BIONEXMedzah IndustriesOPJ2025-07-30
10860011343896BIONEXMedzah IndustriesOPJ2025-07-30
10860011725401BIONEXMedzah IndustriesOPJ2025-07-30