FDA.reportPublic FDA data

Stronghold SMS Isolation Gown (AAMI Level 2)-XL

Primary DI
00850037694761
Brand
Stronghold SMS Isolation Gown (AAMI Level 2)-XL
Company
The Stronghold Group LLC
Model
SC210XL
Device description
This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10.
Published
2022-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850037694815PackageGS110In Commercial Distribution
00850037694761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037694815008500376948158500376948150850037694815
00850037694761008500376947618500376947610850037694761

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Regulatory Flags#

DUNS number
080344373
Device count
1
Premarket exempt
true
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
00850037694648Stronghold PP/PE Isolation Gown (AAMI Level 2)-SSC200S2022-03-19
00850037694655Stronghold PP/PE Isolation Gown (AAMI Level 2)-MSC200M2022-03-19
00850037694662Stronghold PP/PE Isolation Gown (AAMI Level 2)-LSC200L2022-03-19
00850037694679Stronghold PP/PE Isolation Gown (AAMI Level 2)-XLSC200XL2022-03-19
00850037694686Stronghold PP/PE Isolation Gown (AAMI Level 2)-UnisizeSC200U2022-03-19
00850037694730Stronghold SMS Isolation Gown (AAMI Level 2)-SSC210S2022-03-19
00850037694747Stronghold SMS Isolation Gown (AAMI Level 2)-MSC210M2022-03-19
00850037694754Stronghold SMS Isolation Gown (AAMI Level 2)-LSC210L2022-03-19
00850037694778Stronghold SMS Isolation Gown (AAMI Level 2)-UnisizeSC210U2022-03-19
10850037694645Stronghold PP/PE Isolation Gown (AAMI Level 2)-SSC200S2022-03-19
00850037694693Stronghold PP/PE Isolation Gown (AAMI Level 2)-MSC200M2022-03-19
00850037694709Stronghold PP/PE Isolation Gown (AAMI Level 2)-LSC200L2022-03-19
00850037694716Stronghold PP/PE Isolation Gown (AAMI Level 2)-XLSC200XL2022-03-19
00850037694723Stronghold PP/PE Isolation Gown (AAMI Level 2)-UnisizeSC200U2022-03-19
00850037694785Stronghold SMS Isolation Gown (AAMI Level 2)-SSC210S2022-03-19
00850037694792Stronghold SMS Isolation Gown (AAMI Level 2)-MSC210M2022-03-19
00850037694808Stronghold SMS Isolation Gown (AAMI Level 2)-LSC210L2022-03-19
00850037694815Stronghold SMS Isolation Gown (AAMI Level 2)-XLSC210XL2022-03-19
00850037694822Stronghold SMS Isolation Gown (AAMI Level 2)-UnisizeSC210U2022-03-19
00860007372209Stronghold Group Nitrile Examination Glove, Powder Free-SSHFBSNS0603S2022-03-08

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