FDA.report

Indiana Face Mask

Primary DI
B959IFMSM31
Brand
Indiana Face Mask
Company
Fssc LLC
Model
IFM-SM3
Device description
ASTM Level 3 Surgical Mask
Published
2022-07-01
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

Related Records

Contact Domains

Product Codes

CodeName
FXXMask, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K202214000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K202214000IFM Surgical Mask Model SM3Fssc, LLC2021-03-02FXX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B959IFMSM31PackageHIBCC10In Commercial Distribution
B959IFMSM30PrimaryHIBCC0
B959IFMSM300Unit of UseHIBCC0

GMDN Terms

TermDefinition
Surgical/medical face mask, non-antimicrobial, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
2198662270Clayton@ifmasks.com

Regulatory Flags

DUNS number
117675515
Device count
50
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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