Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- ERYDrape, Surgical, Ent2Product Code
- EYXDrape, Pure Latex Sheet, With Self-Retaining Finger Cot2Product Code
- EYYDrape, Urological, Disposable2Product Code
- FXOSuit, Surgical1Product Code
- FXPCover, Shoe, Operating-Room1Product Code
- FXXMask, Surgical2Product Code
- FXYHood, Surgical2Product Code
- FXZHelmet, Surgical1Product Code
- FYAGown, Surgical2Product Code
- FYBGown, Patient2Product Code
- FYCGown, Isolation, Surgical2Product Code
- HMTDrape, Patient, Ophthalmic2Product Code
- HMWDrape, Microscope, Ophthalmic2Product Code
- KGOSurgeon'S Gloves1Product Code
- KGQCream, Gloving, Surgeon'S1Product Code
- KGTDrape, Adhesive, Aerosol1Product Code
- KKXDrape, Surgical2Product Code
- LGXTable, Examination, Medical, Powered1Product Code
- LYUAccessory, Surgical Apparel1Product Code
- K011755STRYKER T4 HYTREL (R) TOGAS1Cleared 510(K)
- K965237NURSES BOUFFANT CAP1Cleared 510(K)
- K970988FAR-EAST BOUFFANT CAPS1Cleared 510(K)
- K964364DISPOSABLE APRON1Cleared 510(K)
- K961791DEPUY DISPOSABLE FILTER/HOOD1Cleared 510(K)
- K961454AMMI MAGNI-GUARD1Cleared 510(K)
- K945302SLOAN STA-DRI PANT PROTECTOR1Cleared 510(K)
- K954314ULTRAFIT LINERS1Cleared 510(K)
- K953089I-SPOUSE1Cleared 510(K)
- K952303SPLASH ASSIST1Cleared 510(K)
- K942200ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS1Cleared 510(K)
- K944276SLOAN STA-DRI BOOTLEG LEGGING1Cleared 510(K)
- K944118SLOAN STA-DRI SURGICAL JUMPSUIT1Cleared 510(K)
- K946003INTEC FULL FACE SHIELD1Cleared 510(K)
- K951420INCASE EXTENSIBLE BAG--NON-STERILE1Cleared 510(K)
- K944763CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER1Cleared 510(K)
- K945098OP-D-OP II1Cleared 510(K)
- K942828MAKAR FULL AND HALF FACE SHIELD1Cleared 510(K)
- K943809MONOGARD FACE SHIELD1Cleared 510(K)
- K940226SHOE COVER1Cleared 510(K)
- K940228BOUFFANT CAP1Cleared 510(K)
- K940723BODY BOOT1Cleared 510(K)
- K941932SPLASH MASK1Cleared 510(K)
- K942022FACE-IT SHIELD1Cleared 510(K)
- K932953DERMAL GLOVES1Cleared 510(K)
- K940274NYLON LINER GLOVES1Cleared 510(K)
- K935158KACEY DISPOSABLE GLOVE LINER1Cleared 510(K)
- K931042MOORE SECURE CAP1Cleared 510(K)
- K935723SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD)1Cleared 510(K)
- K934842TECNOL SPLASHGUARD1Cleared 510(K)
- K931094PROCEL(TM) DERMALINER GLOVE1Cleared 510(K)
- K935779AGAFAR FACE SHIELD1Cleared 510(K)
- K931288ISOLAIR 2 FULL FACE SPLASH GUARD1Cleared 510(K)
- K926438ACTION MEDTEK FACE SHIELD1Cleared 510(K)
- K925290CATALOG NUMBER 111 (FACESHIELD)1Cleared 510(K)
- K925628ULTRATUFF CUT RESISTANT GLOVE LINER1Cleared 510(K)
- K922407WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS1Cleared 510(K)
- K923229MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE1Cleared 510(K)
- K915415GUARDALL SHIELD1Cleared 510(K)
- K915056FINGGUARD1Cleared 510(K)
- K914077REPEL(TM) LITE CUT RESISTANT GLOVE LINERS1Cleared 510(K)
- K912737MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV1Cleared 510(K)
- K912457MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO1Cleared 510(K)
- K910890NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER1Cleared 510(K)
- K911742OP-D-OP VISOR SHIELDS1Cleared 510(K)
- K904903PARADERM(TM) SURGEON'S GLOVE ACCESSORY1Cleared 510(K)
- K900425SURGICAL COTTON GLOVES1Cleared 510(K)
- K902633CUT RESISTANT GLOVE LINER1Cleared 510(K)
- K901221PHYSICIAN BARRIER GLOVE, SURGICAL1Cleared 510(K)
- K902016MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE1Cleared 510(K)
- K900310REPEL SURGICAL GLOVE LINERS1Cleared 510(K)
- K894064STERILE HAND COVER1Cleared 510(K)
- K893842CYSTO APRONS IN VARIOUS SIZES1Cleared 510(K)
- K893118AOR-SULLIVAN PROTECTIVE OVERGLOVE1Cleared 510(K)
- K880440PROTECT-AIDS AUTOPSY UNDERGLOVE1Cleared 510(K)
- K880439PROTECT-AIDS UNDERGLOVE1Cleared 510(K)
- MACDecontamination Kit1Product Code
- MMPCover, Barrier, Protective2Product Code
- MSHRespirator, Surgical2Product Code
- NZPSealant, Microbial2Product Code
- OEANon-Surgical Isolation Gown1Product Code
- OKFBody Fluid Disposal Kit2Product Code
- OKGBody Fluid Clean Up Kit2Product Code
- OKHBody Fluids Barrier Kit2Product Code
- OKIEmergency Response Safety Kit2Product Code
- ONTN95 Respirator With Antimicrobial/Antiviral Agent2Product Code
- OPAPowder-Free Non-Natural Rubber Latex Surgeon'S Gloves1Product Code
- OUKSurgical Mask With Antimicrobial/Antiviral Agent2Product Code
- OVRKit, First Aid, Talking1Product Code
- OXZPediatric/Child Facemask2Product Code
- PIRMercy Tape 2d And 3d Models1Product Code
- PLYAntimicrobial Drapes2Product Code
- PQMSurgical Smoke Precipitator2Product Code
- QBWSurgical Apparel With Material Claims2Product Code
- QMXLabel Or Tag, Non-Sterile1Product Code
- QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection2Product Code
- QSOMedical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ISOLAIR 2 FULL FACE SPLASH GUARD
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K931288
- 510(k) Type
- Traditional
- Applicant
- LOUIS M. GERSON CO., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/21/1994
- Days to Decision
- 315 days
- Submission Type
- Statement