FDA.reportPublic FDA data

Halyard

Primary DI
30680651480348
Brand
Halyard
Company
O&M HALYARD, INC.
Model
48034
Catalog number
48034
Device description
AQUASOFT ZERO* Powder-Free Nitrile Exam Gloves, S
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173942000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173942000Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsCentral Medicare Sdn Bhd2018-03-05LZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651480348PackageGS110In Commercial Distribution
20680651480341PrimaryGS10
90680651480340Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065148034830680651480348
2068065148034120680651480341
9068065148034090680651480340

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen using an enzyme immunohistochemistry method.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
081057389
Device count
300
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
20680651487616PUREZERO* MARIN* XTRA*48761487612022-06-06
20680651487623PUREZERO* MARIN* XTRA*48762487622022-06-06
20680651487630PUREZERO* MARIN* XTRA*48763487632022-06-06
20680651487647PUREZERO* MARIN* XTRA*48764487642022-06-06
20680651487654PUREZERO* MARIN* XTRA*48765487652022-06-06
20680651487661PUREZERO* MARIN*48766487662022-06-06
20680651487678PUREZERO* MARIN*48767487672022-06-06
20680651487685PUREZERO* MARIN*48768487682022-06-06
20680651487692PUREZERO* MARIN*48769487692022-06-06
20680651487708PUREZERO* MARIN*48770487702022-06-06
20680651497639Halyard49763ARMOR242026-07-16
20680651497646Halyard49764ARMOR362026-07-16
20680651497653Halyard49765ARMOR402026-07-16
20680651497660Halyard49766ARMOR452026-07-16
20680651497677Halyard49767ARMOR482026-07-16
20680651497684Halyard49768ARMOR542026-07-16
30680651496936Halyard49693496932025-05-17
30680651496943Halyard49694496942025-05-17
30680651496950Halyard49695496952025-05-17
30680651496967Halyard49696496962025-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160542118HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-28
10809160541722HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541746HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541753HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
10809160541470HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
10809160541487HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
10809160541494HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-23
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
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