FDA.reportPublic FDA data

Halyard

Primary DI
20680651442875
Brand
Halyard
Company
Avanos Medical, Inc.
Model
44287
Catalog number
44287
Device description
STERLING* NITRILE-XTRA* Powder-Free PPE Exam Gloves, S (CE)
Published
2022-02-24
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
LZCPatient examination glove, specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081089000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081089000KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIMKimberly-Clark Corp.2008-07-14LZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651442872PackageGS110In Commercial Distribution
20680651442875PrimaryGS10
90680651442874Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065144287230680651442872
2068065144287520680651442875
9068065144287490680651442874

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.

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
100
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350770997780MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1095816020630-202026-10-20
00350770997797MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1095818020630-242026-10-20
00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095822020640-142026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1095823020640-202026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1095824020640-242026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1095828020644-142026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1095829020644-202026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1095830020644-242026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1095832020645-202026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULL1095833020645-242026-10-20
00350770008998100mL ENFit GPro Syringe Purple Sterile120008323PNM-S100NCV2026-10-19
00350770997742MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1200011280630-142026-10-14
00350770997759MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTW1200011290630-202026-10-14
00350770997766MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTW1200014300630-242026-10-14
00350770997773MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTW1095814020630-142026-10-14
00350770997803MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014310640-142026-10-14
00350770997810MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014320640-202026-10-14
00350770997827MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULL1200014330640-242026-10-14
00350770997865MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULL1200014340644-142026-10-14
00350770997872MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULL1200014350644-202026-10-14

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Primary DI, Brand, Company table
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00850069531225Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
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00199972000702CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531065Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531133Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531140Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531157Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531164Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531171Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
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10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
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10810141933955VIVIT SupplyVivit Supply LLCLZC2026-10-07