FDA.reportPublic FDA data

Standard Surgical Gown (AAMI Level 2)

Primary DI
06973062320420
Brand
Standard Surgical Gown (AAMI Level 2)
Company
Foshan Nanhai Plus Medical Co., Ltd
Model
PM3503SGN
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
K222480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222480000Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)Foshan Nanhai Plus Medical Co, Ltd.2022-11-14FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973062320420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973062320420069730623204206973062320420

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
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
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
06973062320604Standard Surgical Gown (AAMI Level 2)PM3511SGN2026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918196756AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-10-15
16942748412121AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-10-15
16942748480953AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-10-15
00627755521002Lac-MacLac-Mac LimitedFYA2026-10-13
16931918113425AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143040AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143217AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143248AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918153704AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918155159AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
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