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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
ERY
Drape, Surgical, Ent
2
Product Code
EYX
Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
2
Product Code
EYY
Drape, Urological, Disposable
2
Product Code
FXO
Suit, Surgical
1
Product Code
FXP
Cover, Shoe, Operating-Room
1
Product Code
K
97
1076
PRIMED SHOE COVERS, PRIMED HEAD COVERS
1
Cleared 510(K)
K
97
1191
FAR-EAST SHOE COVERS
1
Cleared 510(K)
K
97
0815
CONVERTORS IMPERVIOUS SHOE COVERS
1
Cleared 510(K)
K
96
1342
SHOE COVER, NON-STERILE
1
Cleared 510(K)
K
95
5835
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
1
Cleared 510(K)
K
95
2937
NIOMED NON-SKID SHOE COVERS
1
Cleared 510(K)
K
95
2897
NIOMED SHOE COVERS
1
Cleared 510(K)
K
94
3034
OREX SHOE COVERS
1
Cleared 510(K)
K
93
2738
KAPPLER PRO/VENT BOOT
1
Cleared 510(K)
K
92
5815
REUSABLE LIQUIDPROOF BOOTIE
1
Cleared 510(K)
K
91
4702
STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS
1
Cleared 510(K)
K
91
3628
DISPOSABLE SHOE COVER
1
Cleared 510(K)
K
89
4383
DISPOSABLE SHOE COVER
1
Cleared 510(K)
K
89
3702
TECNOL GAITERS PRODUCT NUMBER 47725-010
1
Cleared 510(K)
K
88
3657
SKID RESISTANT, LONG LASTING SHOE COVERS
1
Cleared 510(K)
K
88
2280
COVER, SHOE OPERATING ROOM
1
Cleared 510(K)
K
88
2128
TECNOL TIGER PAWS PRODUCT NUMBER 47705-010
1
Cleared 510(K)
K
88
0093
CARETEX SKID RESISTANT SHOE COVERS
1
Cleared 510(K)
K
87
4064
SHOE COVERS
1
Cleared 510(K)
K
87
2797
NON-SKID SHOE COVERS
1
Cleared 510(K)
K
86
5023
COVER, SHOE OPERATING ROOM
1
Cleared 510(K)
K
86
4550
CARETEX SHOE COVERS
1
Cleared 510(K)
K
86
4026
NONCONDUCTIVE SHOE COVER
1
Cleared 510(K)
K
86
2726
DISPOSABLE SHOE COVERS AND NURSES CAPS
1
Cleared 510(K)
K
86
1528
TECNOL PERSONAL SHOE COVER
1
Cleared 510(K)
K
85
1554
OVERSHOES (SURCHAUSSURES
1
Cleared 510(K)
K
84
4705
SHOE COVERS
1
Cleared 510(K)
K
84
3475
PHARMA-PLAST SINGLE USE OVERSHOES
1
Cleared 510(K)
K
83
0821
MICRO-MITT
1
Cleared 510(K)
K
80
1617
CONDUCTIVE SHOE COVERS
1
Cleared 510(K)
K
80
1616
NON-CONDUCTIVE SHOE COVERS
1
Cleared 510(K)
K
80
0809
FLARE DIS. CONDUCTIVE&NON. SHOE COVERS
1
Cleared 510(K)
K
80
0528
SHIELD PERFECT FIT; DURA-FIT, DISPOS.
1
Cleared 510(K)
K
78
0590
SHOE COVERS
1
Cleared 510(K)
K
76
1072
P.S.M. JUSTA COVER
1
Cleared 510(K)
K
76
0779
BARNER SHOE COVERS & COVERBOOTS
1
Cleared 510(K)
FXX
Mask, Surgical
2
Product Code
FXY
Hood, Surgical
2
Product Code
FXZ
Helmet, Surgical
1
Product Code
FYA
Gown, Surgical
2
Product Code
FYB
Gown, Patient
2
Product Code
FYC
Gown, Isolation, Surgical
2
Product Code
HMT
Drape, Patient, Ophthalmic
2
Product Code
HMW
Drape, Microscope, Ophthalmic
2
Product Code
KGO
Surgeon'S Gloves
1
Product Code
KGQ
Cream, Gloving, Surgeon'S
1
Product Code
KGT
Drape, Adhesive, Aerosol
1
Product Code
KKX
Drape, Surgical
2
Product Code
LGX
Table, Examination, Medical, Powered
1
Product Code
LYU
Accessory, Surgical Apparel
1
Product Code
MAC
Decontamination Kit
1
Product Code
MMP
Cover, Barrier, Protective
2
Product Code
MSH
Respirator, Surgical
2
Product Code
NZP
Sealant, Microbial
2
Product Code
OEA
Non-Surgical Isolation Gown
1
Product Code
OKF
Body Fluid Disposal Kit
2
Product Code
OKG
Body Fluid Clean Up Kit
2
Product Code
OKH
Body Fluids Barrier Kit
2
Product Code
OKI
Emergency Response Safety Kit
2
Product Code
ONT
N95 Respirator With Antimicrobial/Antiviral Agent
2
Product Code
OPA
Powder-Free Non-Natural Rubber Latex Surgeon'S Gloves
1
Product Code
OUK
Surgical Mask With Antimicrobial/Antiviral Agent
2
Product Code
OVR
Kit, First Aid, Talking
1
Product Code
OXZ
Pediatric/Child Facemask
2
Product Code
PIR
Mercy Tape 2d And 3d Models
1
Product Code
PLY
Antimicrobial Drapes
2
Product Code
PQM
Surgical Smoke Precipitator
2
Product Code
QBW
Surgical Apparel With Material Claims
2
Product Code
QMX
Label Or Tag, Non-Sterile
1
Product Code
QPC
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
2
Product Code
QSO
Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
2
Product Code
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 13 June 2025 at 11:06 pm
HO
/
subpart-e—surgical-devices
/
FXP
/
K843475
View Source
PHARMA-PLAST SINGLE USE OVERSHOES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
ERY
Drape, Surgical, Ent
EYX
Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
EYY
Drape, Urological, Disposable
FXO
Suit, Surgical
FXP
Cover, Shoe, Operating-Room
K
97
1076
PRIMED SHOE COVERS, PRIMED HEAD COVERS
K
97
1191
FAR-EAST SHOE COVERS
K
97
0815
CONVERTORS IMPERVIOUS SHOE COVERS
K
96
1342
SHOE COVER, NON-STERILE
K
95
5835
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
K
95
2937
NIOMED NON-SKID SHOE COVERS
K
95
2897
NIOMED SHOE COVERS
K
94
3034
OREX SHOE COVERS
K
93
2738
KAPPLER PRO/VENT BOOT
K
92
5815
REUSABLE LIQUIDPROOF BOOTIE
K
91
4702
STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS
K
91
3628
DISPOSABLE SHOE COVER
K
89
4383
DISPOSABLE SHOE COVER
K
89
3702
TECNOL GAITERS PRODUCT NUMBER 47725-010
K
88
3657
SKID RESISTANT, LONG LASTING SHOE COVERS
K
88
2280
COVER, SHOE OPERATING ROOM
K
88
2128
TECNOL TIGER PAWS PRODUCT NUMBER 47705-010
K
88
0093
CARETEX SKID RESISTANT SHOE COVERS
K
87
4064
SHOE COVERS
K
87
2797
NON-SKID SHOE COVERS
K
86
5023
COVER, SHOE OPERATING ROOM
K
86
4550
CARETEX SHOE COVERS
K
86
4026
NONCONDUCTIVE SHOE COVER
K
86
2726
DISPOSABLE SHOE COVERS AND NURSES CAPS
K
86
1528
TECNOL PERSONAL SHOE COVER
K
85
1554
OVERSHOES (SURCHAUSSURES
K
84
4705
SHOE COVERS
K
84
3475
PHARMA-PLAST SINGLE USE OVERSHOES
K
83
0821
MICRO-MITT
K
80
1617
CONDUCTIVE SHOE COVERS
K
80
1616
NON-CONDUCTIVE SHOE COVERS
K
80
0809
FLARE DIS. CONDUCTIVE&NON. SHOE COVERS
K
80
0528
SHIELD PERFECT FIT; DURA-FIT, DISPOS.
K
78
0590
SHOE COVERS
K
76
1072
P.S.M. JUSTA COVER
K
76
0779
BARNER SHOE COVERS & COVERBOOTS
FXX
Mask, Surgical
FXY
Hood, Surgical
FXZ
Helmet, Surgical
FYA
Gown, Surgical
FYB
Gown, Patient
FYC
Gown, Isolation, Surgical
HMT
Drape, Patient, Ophthalmic
HMW
Drape, Microscope, Ophthalmic
KGO
Surgeon'S Gloves
KGQ
Cream, Gloving, Surgeon'S
KGT
Drape, Adhesive, Aerosol
KKX
Drape, Surgical
LGX
Table, Examination, Medical, Powered
LYU
Accessory, Surgical Apparel
MAC
Decontamination Kit
MMP
Cover, Barrier, Protective
MSH
Respirator, Surgical
NZP
Sealant, Microbial
OEA
Non-Surgical Isolation Gown
OKF
Body Fluid Disposal Kit
OKG
Body Fluid Clean Up Kit
OKH
Body Fluids Barrier Kit
OKI
Emergency Response Safety Kit
ONT
N95 Respirator With Antimicrobial/Antiviral Agent
OPA
Powder-Free Non-Natural Rubber Latex Surgeon'S Gloves
OUK
Surgical Mask With Antimicrobial/Antiviral Agent
OVR
Kit, First Aid, Talking
OXZ
Pediatric/Child Facemask
PIR
Mercy Tape 2d And 3d Models
PLY
Antimicrobial Drapes
PQM
Surgical Smoke Precipitator
QBW
Surgical Apparel With Material Claims
QMX
Label Or Tag, Non-Sterile
QPC
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
QSO
Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
/
subpart-e—surgical-devices
/
FXP
/
K843475
View Source
PHARMA-PLAST SINGLE USE OVERSHOES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...