FDA.reportPublic FDA data

Plus Medical Cover Gown

Primary DI
16973062321400
Brand
Plus Medical Cover Gown
Company
Foshan Nanhai Plus Medical Co., Ltd
Model
PM4405PG
Published
2022-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213177000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213177000Plus Medical Cover GownFoshan Nanhai Plus Medical Co, Ltd.2022-05-11FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973062321400PackageGS1100In Commercial Distribution
06973062321403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697306232140016973062321400
06973062321403069730623214036973062321403

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
529796225
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973062320406Standard Surgical Gown (AAMI Level 2)PM3501SGN2026-04-24
06973062320413Standard Surgical Gown (AAMI Level 2)PM3502SGN2026-04-24
06973062320420Standard Surgical Gown (AAMI Level 2)PM3503SGN2026-04-24
06973062320437Standard Surgical Gown (AAMI Level 2)PM3504SGN2026-04-24
06973062320444Standard Surgical Gown (AAMI Level 2)PM3505SGN2026-04-24
06973062320451Standard Surgical Gown (AAMI Level 2)PM3501SGS2026-04-24
06973062320468Standard Surgical Gown (AAMI Level 2)PM3502SGS2026-04-24
06973062320475Standard Surgical Gown (AAMI Level 2)PM3503SGS2026-04-24
06973062320482Standard Surgical Gown (AAMI Level 2)PM3504SGS2026-04-24
06973062320499Standard Surgical Gown (AAMI Level 2)PM3505SGS2026-04-24
06973062320505Reinforced Surgical Gown (AAMI Level 2)PM3501RGN2026-04-24
06973062320512Reinforced Surgical Gown (AAMI Level 2)PM3502RGN2026-04-24
06973062320529Reinforced Surgical Gown (AAMI Level 2)PM3503RGN2026-04-24
06973062320536Reinforced Surgical Gown (AAMI Level 2)PM3504RGN2026-04-24
06973062320543Reinforced Surgical Gown (AAMI Level 2)PM3505RGN2026-04-24
06973062320550Reinforced Surgical Gown (AAMI Level 2)PM3501RGS2026-04-24
06973062320567Reinforced Surgical Gown (AAMI Level 2)PM3502RGS2026-04-24
06973062320574Reinforced Surgical Gown (AAMI Level 2)PM3503RGS2026-04-24
06973062320581Reinforced Surgical Gown (AAMI Level 2)PM3504RGS2026-04-24
06973062320598Reinforced Surgical Gown (AAMI Level 2)PM3505RGS2026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
20888277674704MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674711MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674728MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674735MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
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