FDA.reportPublic FDA data

ComPel Surgical Gown

Primary DI
00634916325881
Brand
ComPel Surgical Gown
Company
STANDARD TEXTILE CO., INC.
Model
7565X685
Catalog number
7565X685
Device description
OR GWN COMPEL NEGA BL KAUM L - RM (98 8305) USE: 75656695
Published
2018-01-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYAGown, Surgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041539000COMPEL SURGICAL GOWNSStandard Textile Co., Inc.2005-04-28FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634916325881PrimaryGS10
10634916325881Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634916325881006349163258816349163258810634916325881
1063491632588110634916325881

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, reusableA garment made of natural and/or synthetic materials intended to be worn 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 reusable garment intended to be laundered after each use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-999-0400GUDID@standardtextile.com

Regulatory Flags#

DUNS number
006999858
Device count
24
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634916788358ComPel OR Gown756474542023-10-10
00634916005523Barrier Supreme Wrapper21623002216230022018-01-29
00634916070187Precaution/Isolation Gown66106701661067012018-01-29
00634916019353Standard Supreme966893632026-03-11
00634916099225INSTRUMENT COVER965005122026-03-11
00634916120905Instrument Holder969007152026-03-11
00634916349740Compel MLR OR Gown7567B2162026-03-11
00634916781373WrapPel Table Cover969017842026-03-11
00634916788105Compel MLR OR Gown756747432026-03-11
00634916788112Compel MLR OR Gown756747442026-03-11
00634916788129Compel MLR OR Gown756747452026-03-11
00634916789249ProMax Surgical Gown756747652026-03-11
00634916789256ProMax Surgical Gown,756747642026-03-11
00634916789263ProMax Surgical Gown,756747632026-03-11
00634916792775OR Gown756748362026-03-11
00634916796322ComPel Surgical Gown756566G32026-03-11
00634916796339ComPel Surgical Gown756566G42026-03-11
00634916796346ComPel Surgical Gown756566G52026-03-11
00634916797114Reusable Gown 661YUAG42026-03-11
00634916797121Reusable Gown661YUAG52026-03-11

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Primary DI, Brand, Company table
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16931918153704AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
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16931918182988AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918192208AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918195544AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918198286AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
04719882251900CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251924CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251948CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251962CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
09009607835207ViVi® PEEL-OFF TOGA PREMIUM XL-XXLTHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835214ViVi® PEEL-OFF TOGA PREMIUM M-LTHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835221ViVi® PEEL-OFF TOGA PREMIUM XXS-STHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835238ViVi® PEEL-OFF TOGA PREMIUM 3XLTHI Total Healthcare Innovation GmbHFYA2026-07-22
10193489135909MEDLINEMEDLINE INDUSTRIES, INC.FYA2026-07-17
04719882251887CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-06-25
50885380134560CARDINAL HEALTHCardinal Health 200, LLCFYA2026-06-24
16931918123325AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-06-04
08809518442430SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442447SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
20888277720050MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-11
20888277419879MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277419886MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277660905MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10