FDA.reportPublic FDA data

Halyard

Primary DI
30680651487637
Brand
Halyard
Company
Avanos Medical, Inc.
Model
48763
Catalog number
48763
Device description
HYH,LFS,PUREZERO GLOVE,BU,M
Published
2022-06-06
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
QDOFentanyl and other opioid protection glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220547000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220547000PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.2022-06-02LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651487637PackageGS110In Commercial Distribution
20680651487630PrimaryGS10
90680651487639Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065148763730680651487637
2068065148763020680651487630
9068065148763990680651487639

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273PIQ@hyh.com

Regulatory Flags#

DUNS number
079375431
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
true
Expiration date on label
true
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
00193493001088SINGLE SHOT EPIDURAL TRAY120008532182A2732026-08-21
00350770006840CORTRAK* Enteral Access System120008508P20-09502026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable Cable12000625220-09662026-08-21
00350770009094CORTRAK* Enteral Access System12000890420-09502026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable Cable12000887220-09662026-08-21
00350770007557CORFLO* Safety PEG Kit12000866230-53202026-08-14
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® Connector120004764BA-S05NC2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® Connector120004831BA-S12NC2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® Connector120004839BA-S60NC2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® Connector120004765BP-S05NC2026-08-15
00350770008929NEOMED* Oral / Enteral Syringe with ENFit® Connector120004842BP-S12NC2026-08-15
00350770008943NEOMED* Oral / Enteral Syringe with ENFit® Connector120004847BP-S60NC2026-08-15
00350770008967NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004849NEO122026-08-15
00350770008981NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004852NEO602026-08-15
00350770009001NEOMED* Oral / Enteral Syringe with ENFit® Connector120004832BA-S12NC-S2026-08-15
00350770009018NEOMED* Oral / Enteral Syringe with ENFit® Connector120004869PNM-S12NC2026-08-15
00350770009032NEOMED* Oral / Enteral Syringe with ENFit® Connector120004874PNM-S35NC2026-08-15
00812120004895Game Ready* System120008544550500-042026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, Medium120008563590923-042026-07-31
00812120005113Game Ready* Ankle Wrap, Large120008549590330-042026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850005229803NeulynxMedgluv Inc.QDO2026-07-17
00850005229810NeulynxMedgluv Inc.QDO2026-07-17
00850005229827NeulynxMedgluv Inc.QDO2026-07-17
00850005229834NeulynxMedgluv Inc.QDO2026-07-17
00850005229841NeulynxMedgluv Inc.QDO2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.QDO2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.QDO2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.QDO2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.QDO2026-07-14
00810169610312NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810145952115NeuleafMedgluv Inc.QDO2026-06-30
00810145952122NeuleafMedgluv Inc.QDO2026-06-30
00810145952139NeuleafMedgluv Inc.QDO2026-06-30
00810145952146NeuleafMedgluv Inc.QDO2026-06-30
00810145952429NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952436NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952443NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952450NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952467NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952108NeuleafMedgluv Inc.QDO2026-06-29
00850005229568NeuflexMedgluv Inc.QDO2026-06-29
00850005229575NeuflexMedgluv Inc.QDO2026-06-29
00850005229582NeuflexMedgluv Inc.QDO2026-06-29
00850005229599NeuflexMedgluv Inc.QDO2026-06-29
00850005229605NeuflexMedgluv Inc.QDO2026-06-29
00850005229612NeuflexMedgluv Inc.QDO2026-06-29