FDA.reportPublic FDA data

Procedure Mask 3 ply level 1, color 50 per box, BLACK

Primary DI
B958FM3881
Brand
Procedure Mask 3 ply level 1, color 50 per box, BLACK
Company
Excel Gloves & Safety Supplies, Inc.
Model
FM BLACK
Device description
Procedure Mask 3 ply level 1, color 50 per box color black
Published
2024-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202708000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202708000Surgical Face MasksIntco Medical(Hk) Co., Ltd.2021-03-30FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B958FM388BLK1PrimaryHIBCC0
B958FM3881Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
928913409
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B958EB3310EXCEL Bio GlovesEB3310EB33102025-09-16
B958EB336EXCEL Bio GlovesEB336EB3362025-09-16
B958EB337EXCEL Bio GlovesEB337EB3372025-09-16
B958EB338EXCEL Bio GlovesEB338EB3382025-09-16
B958EB339EXCEL Bio GlovesEB339EB3392025-09-16
B958FM388BLK1Procedure Mask 3 ply level 1, color 50 per box, BLACKFM BLACK2024-09-06
B958FM388G1EXCEL Procedure Mask 3 ply level 1, 50 per box, mint greenFM 388G Mint Green0503FM388G2024-09-06
B95848861ICONICON 4886ICON48862023-08-02
B958E20861EXCELEXCEL E2086EXCEL E20862023-08-02
B958E20871EXCELEXCEL E2087EXCEL E20872023-08-02
B958E20881EXCELEXCEL E2088EXCEL E20882023-08-02
B958EM18871EXCELEXCEL EM1887EM18872023-08-02
B958EM18881EXCELEXCEL EM1888EM18882023-08-02
B958EM18891EXCELEXCEL EM1889EM18892023-08-02
B958EPF28861EXCELPRIMERA EPF2886EPF28862023-08-02
B958EPF28871EXCELPRIMERA EPF2887EPF28872023-08-02
B958EPF28881EXCELPRIMERA EPF2888EPF28882023-08-02
B958EPF28891EXCELPRIMERA EPF2889EPF28892023-08-02
B958ESL8100101EXCELAXON ESL810010ESL810092023-08-02
B958ESL810061EXCELAXON ESL81006ESL810062023-08-02

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00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
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