FDA.reportPublic FDA data

Stronghold SMS Isolation Gown (AAMI Level 2)-XL

Primary DI
00850037694815
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
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080344373
Device count
1
DM exempt
false
Premarket exempt
true
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
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
00850037694822Stronghold SMS Isolation Gown (AAMI Level 2)-UnisizeSC210U2022-03-19
00860007372247Stronghold Group Nitrile Examination Glove, Powder Free-SSHFBSNS0603S2022-03-08
00860007372254Stronghold Group Nitrile Examination Glove, Powder Free-MSHFBSNS0603M2022-03-08
00860007372261Stronghold Group Nitrile Examination Glove, Powder Free-LSHFBSNS0603L2022-03-08
00860007372278Stronghold Group Nitrile Examination Glove, Powder Free-XLSHFBSNS0603XL2022-03-08
00711583360954LYDUS Nitrile Examination Gloves, Powder FreeFRSNS-LYDUSNTRL2022-02-27
00850037694006Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-MSC300M2021-11-25
00850037694051Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-LSC300L2021-11-25
00850037694068Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-XLSC300XL2021-11-25
00850037694075Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-XXLSC300XXL2021-11-25
00850037694129Stronghold SMS Reinforced Surgical Gown (Sterile)-MSC301M2021-11-25
00850037694136Stronghold SMS Reinforced Surgical Gown (Sterile)-LSC301L2021-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196163885MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110003MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110010MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110072MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
00634916797114Reusable Gown STANDARD TEXTILE CO., INC.OEA2026-03-11
00634916797121Reusable GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916797459ComPel Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916881356Reversible Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916881363Reversible Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
10810132044356HCSConcordance Healthcare Solutions LLCOEA2026-03-09
20810132044360HCS SourcingConcordance Healthcare Solutions LLCOEA2026-03-09
40080196765523MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-05
10197344158881MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158904MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158928MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158942MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158966MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158997MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159000MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159024MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159031MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159048MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159055MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159062MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159079MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159086MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159093MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159116MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159123MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344200474MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03