FDA.reportPublic FDA data

Amerishield

Primary DI
10860004941917
Brand
Amerishield
Company
Premiumestore, LLC
Model
PPE-M-AS-SUR-LVL2-S
Device description
Premium-PPE Amerishield Surgical Mask, ASTM Level 2, 3-Ply Adult Blue, Outer Case of 2,000 Masks, 40 inner boxes per case, K211520
Published
2022-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K211520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211520000Amerishield Surgical MaskPremiumestore, LLC2021-06-15FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860004941917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086000494191710860004941917

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in indoor conditions. Avoid heat, light, and excessive humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-267-1801support@premium-ppe.com

Regulatory Flags#

DUNS number
014851503
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860004941910AmerishieldPPE-M-AS-SUR-LVL2-S2022-06-24
00860004941927AmerishieldPPE-M-AS-SUR-S2022-06-23
10860004941924Amerishield PPE-M-AS-SUR-S2022-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344219237MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-31
06974960061330S&JXiantao S&J Protective Products Co., LtdFXX2026-07-29
00840456202814JMUJMU DENTAL, INCFXX2026-07-24
00840456202807JMUJMU DENTAL, INCFXX2026-07-23
00840456214664JMUJMU DENTAL, INCFXX2026-07-23
00840456214671JMUJMU DENTAL, INCFXX2026-07-23
00840456214688JMUJMU DENTAL, INCFXX2026-07-23
00840456214695JMUJMU DENTAL, INCFXX2026-07-23
30197344201697MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-20
00810145950975NeuMask PinkMedgluv Inc.FXX2026-07-17
00850005229728NeuMask OrangeMedgluv Inc.FXX2026-07-17
00850086117037Resilient Medical SolutionsResilient Medical Solutions, LLCFXX2026-07-08
00840456202722JMUJMU DENTAL, INCFXX2026-07-07
00840456202739JMUJMU DENTAL, INCFXX2026-07-07
00840456202746JMUJMU DENTAL, INCFXX2026-07-07
00840456214619JMUJMU DENTAL, INCFXX2026-07-07
00840456214626JMUJMU DENTAL, INCFXX2026-07-07
00840456214633JMUJMU DENTAL, INCFXX2026-07-07
00840456214640JMUJMU DENTAL, INCFXX2026-07-07
00840456214657JMUJMU DENTAL, INCFXX2026-07-07
00810145952696NeuMask BlackMedgluv Inc.FXX2026-06-30
00850056441261Target Up&UpTARGET CORPORATIONFXX2026-06-25
00850056441254Target Up&UpTARGET CORPORATIONFXX2026-06-25
16980077680262AOKAOK TOOLING LIMITEDFXX2026-06-24
16980077680255AOKAOK TOOLING LIMITEDFXX2026-06-22
00842942008894PRIMEDpriMED Medical Products IncFXX2026-06-21
06922820992584GraidRfx+Care Manufacturing Co., Ltd.FXX2026-06-09
16980077680217AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680224AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680231AOKAOK TOOLING LIMITEDFXX2026-06-08