FDA.reportPublic FDA data

ProtectX

Primary DI
20860005250060
Brand
ProtectX
Company
The Azac Group
Model
LTF-0218-25-B
Catalog number
LTF-0218-25-B
Device description
AAMI LEVEL 3 DISPOSABLE PROTECTIVE GOWN OVER THE HEAD WITH THUMB LOOP NONSTERILE EXTRA LARGE BLUE
Published
2022-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier ProtectionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211538000Protect X Level 3 Isolation GownAzac Group2021-11-17FYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30860005250067PackageGS12In Commercial Distribution
40860005250064PackageGS18In Commercial Distribution
50860005250061PackageGS120In Commercial Distribution
20860005250060PrimaryGS10
10860005250063Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3086000525006730860005250067
4086000525006440860005250064
5086000525006150860005250061
2086000525006020860005250060
1086000525006310860005250063

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
067056009
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20860005250039ProtectXLTF-0218-25LTF-0218-252022-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10326053121491Regard™Resource Optimization & Innovation, L.L.C.QPC2024-11-28
10326053121507Regard™Resource Optimization & Innovation, L.L.C.QPC2024-11-28
10326053121514Regard™Resource Optimization & Innovation, L.L.C.QPC2024-11-28
20326053121498Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.QPC2024-11-28
20326053121504Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.QPC2024-11-28
20326053121511Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.QPC2024-11-28
10197344036301MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-09-02
20197344036308MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-09-02
10197344036318MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-08-13
10197344036325MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-08-13
30197344036312MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-08-13
30197344036329MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-08-13
00612899045484EncompassEncompass Group, L.L.C.QPC2023-06-22
00612899101104EncompassEncompass Group, L.L.C.QPC2023-06-22
20860005250039ProtectXThe Azac GroupQPC2022-04-07
20192253003816CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
20192253003823CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
20192253003830CARDINAL HEALTHCARDINAL HEALTH 200, LLCQPC2019-05-10
20192253003847CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
20192253003854CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
50192253003817CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
50192253003824CARDINAL HEALTHCARDINAL HEALTH 200, LLCQPC2019-05-10
50192253003831CARDINAL HEALTHCARDINAL HEALTH 200, LLCQPC2019-05-10
50192253003848CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
50192253003855CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10