FDA.reportPublic FDA data

ComPel Surgical Gown

Primary DI
00634916005752
Brand
ComPel Surgical Gown
Company
STANDARD TEXTILE CO., INC.
Model
75656695
Catalog number
75656695
Device description
OR GWN ULT COMPEL NEGA BL L - 2PLY FRT/SLV-BL NK-TIE NK/WST
Published
2018-01-29
Public version status
Update
Distribution status
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
00634916005752PrimaryGS10
10634916005752Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634916005752006349160057526349160057520634916005752
1063491600575210634916005752

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
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
00634916797459ComPel Isolation Gown6610359V2026-03-11
00634916829358ProMax Surgical Gown756150762026-03-11
00634916870633Instrument Drape966008322026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
09009607822207ViVi TOGA Premium Size XL-XXLTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607822214ViVi TOGA Premium Size M-LTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607822221ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832206ViVi TOGA Premium Size XL-XXLTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832213ViVi TOGA Premium Size M-LTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832220ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
07613327625196Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625219Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625226Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625240Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625257Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625264Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625271Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625288Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625295Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625301Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625318Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625325Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625332Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625349Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625356Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625363Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625370Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625387Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625394Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625400Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21