FDA.reportPublic FDA data

PHARMA-GLOVE CR

Primary DI
10075289715249
Brand
PHARMA-GLOVE CR
Company
McGowan Enterprises, Inc.
Model
CRPGNS12-XS
Catalog number
CRPGNS12-XS
Device description
"CLEAN ROOM PROCESS, NITRILE EXAMINATION GLOVES, NON-STERILE, 12"" LENGTH, CHEMO TESTED, WHITE, X-SMALL"
Published
2022-11-15
Public version status
New
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
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
20075289715246PackageGS11000In Commercial Distribution
10075289715249PrimaryGS10
00075289715242Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2007528971524620075289715246
1007528971524910075289715249
00075289715242000752897152420752897152420075289715242

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.

Contacts#

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

Regulatory Flags#

DUNS number
029901019
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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
10075289715256PHARMA-GLOVE CRCRPGNS12-SCRPGNS12-S2022-11-15
10075289715263PHARMA-GLOVE CRCRPGNS12-MCRPGNS12-M2022-11-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810145951996NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145952009NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145952153NeulynxMedgluv Inc.OPJ2026-06-26
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
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10857420007624EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09