FDA.reportPublic FDA data

Halyard

Primary DI
30680651416606
Brand
Halyard
Company
O&M HALYARD, INC.
Model
41660
Catalog number
41660
Device description
HALYARD* STERLING SG* Powder-Free Nitrile Exam Glove, L
Published
2020-09-15
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
LZCPatient examination glove, specialty

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651416606PackageGS110In Commercial Distribution
20680651416609PrimaryGS10
90680651416608Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065141660630680651416606
2068065141660920680651416609
9068065141660890680651416608

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
081057389
Device count
250
DM exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30680651489532Halyard48953489532026-03-12
30680651497285Halyard49728497282026-03-04
30680651497292Halyard49729497292026-03-04
30680651497308Halyard49730497302026-03-04
30680651497315Halyard49731497312026-03-04
30680651497322Halyard49732497322026-03-04
30680651596810Halyard59681596812020-11-16
30680651596889Halyard59688596882020-11-16
30680651331015Halyard33101331012020-11-16
30680651331503Halyard33150331502020-11-16
30680651332012Halyard33201332012020-11-16
30680651334955Halyard33495334952020-11-16
30680651335006Halyard33500335002020-11-16
30680651337253Halyard33725337252020-11-16
90680651335107Halyard33510335102020-11-16
90680651337248Halyard33724337242020-11-16
30680651493645Halyard49364493642025-09-23
30680651493652Halyard49365493652025-09-23
30680651493409Halyard49340493402025-09-19
30680651493423Halyard49342493422025-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850006162611Aloe-ShieldClinical Supply CompanyLZC2026-03-24
00850006162628Aloe-ShieldClinical Supply CompanyLZC2026-03-24
00850006162796Aloe-ShieldClinical Supply CompanyLZC2026-03-24
00850006162758Aloe-ShieldClinical Supply CompanyLZC2026-03-24
00850006162765Aloe-ShieldClinical Supply CompanyLZC2026-03-24
30680651489532HalyardO&M HALYARD, INC.LZC2026-03-12
00810194400278AiraAIRA, LLCLZC2026-02-10
00810007662534HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662541HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662558HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662565HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662572HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00810007662602HANDPROHOURGLASS INTERNATIONAL INCLZC2025-12-15
00847713001340microdot® FlexCambridge Sensors USA LLCLZC2025-12-12
00847713001258microdot® FlexCambridge Sensors USA LLCLZC2025-12-12
10842942014151PRIMEDpriMED Medical Products IncLZC2025-11-18
40080196334255MEDLINEMEDLINE INDUSTRIES, INC.LZC2025-07-17
00810194400261AiraAIRA, LLCLZC2025-07-16
00850061859174GCB Medical SupplyGCB MEDICAL LLCLZC2025-07-09
00850061859082GCB Medical SupplyGCB MEDICAL LLCLZC2025-07-09
00850061859198GCB Medical SupplyGCB MEDICAL LLCLZC2025-07-09
20076490730592KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490748658KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490754888KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490755069KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490763101KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490763743KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490768878KIMTECHAnsell Healthcare ProductLZC2025-07-03
20076490723617KIMTECHAnsell Healthcare ProductLZC2025-07-02
20076490730158KIMTECHAnsell Healthcare ProductLZC2025-07-02