FDA.reportPublic FDA data

Plus Medical Isolation Gown Level 3

Primary DI
16973062321325
Brand
Plus Medical Isolation Gown Level 3
Company
Foshan Nanhai Plus Medical Co., Ltd
Model
PM4405FG
Published
2022-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FYCGown, Isolation, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYCGown, Isolation, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212698000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212698000Plus Medical Isolation Gown Level 3Foshan Nanhai Plus Medical Co, Ltd.2022-03-02FYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973062321325PackageGS110In Commercial Distribution
06973062321328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697306232132516973062321325
06973062321328069730623213286973062321328

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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00688162390506ProtexerICP MEDICAL, LLCFYC2025-08-08
10813360021465ProtexerICP MEDICAL, LLCFYC2025-08-08
00813360021772ProtexerICP MEDICAL, LLCFYC2025-08-08
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