FDA.reportPublic FDA data

Surgical Gowns

Primary DI
00616784819235
Brand
Surgical Gowns
Company
Dynarex Corporation
Model
8192
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K111067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111067000JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILEKunshan Jiehong Nonwoven Product Co., Ltd.2011-08-02FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784819235PrimaryGS10
00616784819211Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784819235006167848192356167848192350616784819235
00616784819211006167848192116167848192110616784819211

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA 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 single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00840117336483Steel Button Folding Walker with 5 Wheels, Adults101702024-06-17
00616784020013DynaGo Zoom - Aluminum Rollator with 3" Wheels102002019-10-07
00616784020112Vivid-Quad, Rollator, With 6" Caster , Blue10201BL2019-10-07
00616784020211Vivid-Terrain, Rollator with 7.5" Caster102022019-10-07
00616784020310Titan-500 Bariatric Rollator102032019-10-07
00616784020129Vivid-Quad, Rollator, With 6" Caster, Red10201RD2019-11-07
00616784020136Vivid-Quad, Rollator, With 6" Caster, Black10201BK2019-11-07
00616784020143Vivid-Quad, Rollator, With 6" Caster, Pink10201PK2019-11-07
00616784016016DMECare Solutions Two Button Folding Walker, Adult (32"-39")101602019-10-01
00616784016412Side Style One Arm Walker101642019-10-01
00616784016511Bariatric Dual Release Folding Walker101652019-10-01
00616784016610Bariatric Dual Release Folding Walker w/ Wheels101662019-10-01
00840117304086Stand Up Cane, Black101392021-09-01
00616784011011Forearm Crutches - Youth, 4'2" - 5'2"101102019-09-30
00616784011110Forearm Crutches - Adult, 5'0" - 6'2"101112019-09-30
00616784011219Forearm Crutches - Tall, 5'10" - 6'6"101122019-09-30
00616784013114Round Handle Cane with Vinyl Grip101312019-09-30
00616784013213Round Handle Cane with Foam Grip101322019-09-30
00616784013312Offset Cane, Black101332019-09-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
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20888277674704MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
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20888277674728MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
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