FDA.reportPublic FDA data

PROTECT 800

Primary DI
00075289715204
Brand
PROTECT 800
Company
McGowan Enterprises, Inc.
Model
PROSNCG-L
Catalog number
PROSNCG-L
Device description
"SURGICAL GLOVE, STERILE, NITRILE, 12"" LENGTH, CHEMO TESTED, POWDER FREE, WHITE, LARGE"
Published
2022-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
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
10075289715201PackageGS150In Commercial Distribution
20075289715208PackageGS1200In Commercial Distribution
00075289715204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007528971520110075289715201
2007528971520820075289715208
00075289715204000752897152040752897152040075289715204

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile surgical glove, non-powderedA sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder and it does not have antimicrobial features. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, 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
Radiation Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
029901019
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
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
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
10075289715263PHARMA-GLOVE CRCRPGNS12-MCRPGNS12-M2022-11-15

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Primary DI, Brand, Company table
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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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