FDA.reportPublic FDA data

PHARMA-GLOVE CR

Primary DI
20075289715307
Brand
PHARMA-GLOVE CR
Company
McGowan Enterprises, Inc.
Model
CRPGNS12-3XL
Catalog number
CRPGNS12-3XL
Device description
CLEAN ROOM PROCESS, NITRILE EXAMINATION GLOVES, NON-STERILE, 12" LENGTH, CHEMO TESTED, WHITE, 3XL
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
20075289715307PackageGS11000In Commercial Distribution
10075289715300PrimaryGS10
00075289715303Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2007528971530720075289715307
1007528971530010075289715300
00075289715303000752897153030752897153030075289715303

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

Contacts#

Phone, Email table
PhoneEmail
888-909-7700dmcgowan@acutecareonline.com

Regulatory Flags#

DUNS number
029901019
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
false
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
00075289715310PHARMA-GLOVE-LTCPGNS12-LTC-XSPGNS12-LTC-XS2022-11-15
00075289715327PHARMA-GLOVE-LTCPGNS12-LTC-SPGNS12-LTC-S2022-11-15
00075289715334PHARMA-GLOVE-LTCPGNS12-LTC-MPGNS12-LTC-M2022-11-15
00075289715341PHARMA-GLOVE-LTCPGNS12-LTC-LPGNS12-LTC-L2022-11-15
00075289715358PHARMA-GLOVE-LTCPGNS12-LTC-XLPGNS12-LTC-XL2022-11-15
00075289715365PHARMA-GLOVE-LTCPGNS12-LTC-2XLPGNS12-LTC-2XL2022-11-15
00075289715372PHARMA-GLOVE-LTCPGNS12-LTC-3XLPGNS12-LTC-3XL2022-11-15
00075289715389PHARMA-GLOVEPGNS12-XSPGNS12-XS2022-11-15
00075289715396PHARMA-CHOICEPGNS12-SPGNS12-S2022-11-15
00075289715402PHARMA-CHOICEPGNS12-MPGNS12-M2022-11-15
00075289715419PHARMA-GLOVEPGNS12-LPGNS12-L2022-11-15
00075289715426PHARMA-CHOICEPGNS12-XLPGNS12-XL2022-11-15
00075289715433PHARMA-CHOICEPGNS12-2XLPGNS12-2XL2022-11-15
00075289715440PHARMA-CHOICEPGNS12-3XLPGNS12-3XL2022-11-15
00075289715228PROTECT 800PROSNCG-SPROSNCG-S2022-12-30
00075289715204PROTECT 800PROSNCG-LPROSNCG-L2022-12-21
00075289715211PROTECT 800PROSNCG-MPROSNCG-M2022-12-21
00075289715235PROTECT 800PROSNCG-XLPROSNCG-XL2022-12-21
10075289715249PHARMA-GLOVE CRCRPGNS12-XSCRPGNS12-XS2022-11-15
10075289715256PHARMA-GLOVE CRCRPGNS12-SCRPGNS12-S2022-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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10076490788664MICROFLEX Ansell Healthcare ProductOPJ2025-08-05
10076490788671MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
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10076490788695MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10860011343872BIONEXMedzah IndustriesOPJ2025-07-30
10860011343889BIONEXMedzah IndustriesOPJ2025-07-30
10860011343896BIONEXMedzah IndustriesOPJ2025-07-30
10860011725401BIONEXMedzah IndustriesOPJ2025-07-30
10860011725418BIONEXMedzah IndustriesOPJ2025-07-30
10076490708495KIMTECHAnsell Healthcare ProductOPJ2025-07-21
10076490714397KIMTECHAnsell Healthcare ProductOPJ2025-07-21
10076490723740KIMTECHAnsell Healthcare ProductOPJ2025-07-21
10076490737334KIMTECHAnsell Healthcare ProductOPJ2025-07-21