FDA.reportPublic FDA data

SKYPRO

Primary DI
04897030537042
Brand
SKYPRO
Company
SKYPRO ENTERPRISE LIMITED
Model
SP01
Catalog number
FP3FNWH
Device description
Skypro, SP01 Mask is intended to be used by healthcare personnel to protect themselves and patients from the transfer of microorganisms, body fluids, and particulate matter.
Published
2020-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K152197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152197000Skypro, SP01 MaskSkypro Medical Supplies Company2016-08-26FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04897030530968PackageGS140In Commercial Distribution
04897030537042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04897030530968048970305309684897030530968
04897030537042048970305370424897030537042

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, 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) during medical procedures and patient examination; 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 intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
668172323
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897030530975SKYPROSP01FP3FNWH 2021-07-22
04897030530982SKYPROSP01FP3FNWH 2021-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G539MM3S1Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3S2Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3SB1Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3SB2Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
00050428143315CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXX2026-09-18
00050428340561CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXX2026-09-18
10304040195472EssentialsHENRY SCHEIN, INC.FXX2026-09-04
10304040195489EssentialsHENRY SCHEIN, INC.FXX2026-09-04
00810194402623AiraAIRA, LLCFXX2026-08-26
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