FDA.reportPublic FDA data

Shoe cover (35gsm PP half elastic) [EMS-10221]

Primary DI
20376885023019
Brand
Shoe cover (35gsm PP half elastic) [EMS-10221]
Company
Emergency Medical Solutions LLC
Model
EMS-10221
Device description
Shoe cover (35gsm PP half elastic) [EMS-10221]
Published
2021-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FXPCover, Shoe, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20376885023019PrimaryGS10
00376885023015Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2037688502301920376885023019
00376885023015003768850230153768850230150376885023015

GMDN Terms#

Term, Definition table
TermDefinition
Shoe coverA loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117478411
Device count
1000
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
2037688502601040gsm PP Bouffant Cap EMS-081312021-05-12
2037688502701735gsm sms Bouffant CapEMS-082412021-05-12
2037688502901120gsm PP Bouffant CapEMS-081212021-05-12
20376885031014Surgical Cap (tie back) Non-sterile (35gsm SMS) EMS-092112021-05-12
20376885032011Surgical Cap (tie back) Non-sterile (30g SMS) EMS-091412021-05-12
20376885033018Surgical Cap (tie back) Non-sterile (35g SMS)EMS-092512021-05-12
20376885034015Surgical Cap (tie back) Non-sterile (30g PP)EMS-091212021-05-12
20376885035012Beard Cover (20gsm PP) [EMS-12111]EMS-121112021-05-12
20376885036019Head and Beard Cover Combined Cover (20gsm PP) [EMS-13111]EMS-131112021-05-12
30376885028011Nurse Cap 35gsm SMSEMS-082512021-05-12
3037688503001416gsm PP Bouffant CapEMS-081112021-05-12
20376885018015 Knee high boot covers (45g SMS)EMS-11211B2021-05-12
20376885019012 Knee high boot covers (45g SMS)EMS-112222021-05-12
20376885020018 Knee high boot covers (45g SMS)EMS-112112021-05-12
20376885021015Knee high boot cover (40g SMS)EMS-113112021-05-12
20376885022012Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411]EMS-114112021-05-12
20376885024016Shoe cover (33gsm PP full elastic) [EMS-10211]EMS-102112021-05-12
20376885025013Shoe cover (40gsm PP half elastic) [EMS-10232]EMS-102322021-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456217566JMUJMU DENTAL, INCFXP2026-07-07
00860012300792JMUJMU DENTAL, INCFXP2026-07-07
00199536901209BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901216BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901223BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901230BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901247BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901254BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901261BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901278BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
20197344164049MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-30
20197344133120MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
20197344151575MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
10197344103973MEDLINEMEDLINE INDUSTRIES, INC.FXP2025-04-05
10810141933214VIVIT SupplyVivit Supply LLCFXP2024-11-29
10810141933221VIVIT SupplyVivit Supply LLCFXP2024-11-29
10850053289504SURGYCOSurgyco LLCFXP2024-08-09
20197344036117MedlineMEDLINE INDUSTRIES, INC.FXP2024-02-16
20197344074454MedlineMEDLINE INDUSTRIES, INC.FXP2024-02-16
20197344036049MedlineMEDLINE INDUSTRIES, INC.FXP2024-01-01
20197344036056MedlineMEDLINE INDUSTRIES, INC.FXP2024-01-01
20197344029607MedlineMEDLINE INDUSTRIES, INC.FXP2023-12-22
20197344029614MedlineMEDLINE INDUSTRIES, INC.FXP2023-12-19
30080196745795MedlineMEDLINE INDUSTRIES, INC.FXP2023-10-12
10810141930435VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930442VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930626Vivit SupplyVivit Supply LLCFXP2023-09-15
10810141930633VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930923VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930930VIVIT SupplyVivit Supply LLCFXP2023-09-15