FDA.reportPublic FDA data

Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-XXL

Primary DI
00850037694075
Brand
Stronghold SMS Reinforced Surgical Gown (Non-Sterile)-XXL
Company
The Stronghold Group LLC
Model
SC300XXL
Device description
The Stronghold SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
Published
2021-11-25
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
FYAGown, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850037694075PackageGS125In Commercial Distribution
00850037694037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037694075008500376940758500376940750850037694075
00850037694037008500376940378500376940370850037694037

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
080344373
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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
00850037694815Stronghold SMS Isolation Gown (AAMI Level 2)-XLSC210XL2022-03-19
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
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
00634916349740Compel MLR OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916788105Compel MLR OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916788112Compel MLR OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916788129Compel MLR OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916789249ProMax Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916789256ProMax Surgical Gown,STANDARD TEXTILE CO., INC.FYA2026-03-11
00634916789263ProMax Surgical Gown,STANDARD TEXTILE CO., INC.FYA2026-03-11
00634916792775OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916796322ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916796339ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916796346ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916829358ProMax Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916880205ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916880816ComPel Surgical Gown,STANDARD TEXTILE CO., INC.FYA2026-03-11
00634916880823ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916899627ProMax Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
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