FDA.reportPublic FDA data

supmedic

Primary DI
08101601829860
Brand
supmedic
Company
Supmedics Inc.
Model
SKF-XL-1302
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212578000Nitrile disposable examination glovesXingyu Medical Tech Co., Ltd.2021-12-02LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08101601829860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08101601829860081016018298608101601829860

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

Regulatory Flags#

DUNS number
107150886
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810160180005BEASTEKBTN14422024-11-04
00810160180012BEASTEKBTN14432024-11-04
00810160180043BeastekBTN24422024-10-02
00810160183549supUNE-XL-151052026-01-26
08101601833584supUNE-S-131022026-01-26
08101601833652supUNE-M-131032026-01-26
08101601833720supUNE-L-131042026-01-26
08101601833898supUNE-XL-131052026-01-26
08101601834338supUNE-S-141022026-01-26
08101601834406supUNE-M-141032026-01-26
08101601834574supUNE-L-141042026-01-26
08101601834642supUNE-XL-141052026-01-26
08101601835182supUNE-S-151022026-01-26
08101601835250supUNE-M-151032026-01-26
08101601835328supUNE-L-151042026-01-26
08101601835946supUNE-S-161022026-01-26
08101601836004supUNE-M-161032026-01-26
08101601836172supUNE-L-161042026-01-26
08101601836240supUNE-XL-161052026-01-26
08101601836790SUPUNM-S-141122026-01-26

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Primary DI, Brand, Company table
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00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952153NeulynxMedgluv Inc.LZA2026-06-26
10304040194048EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194055EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194062EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194079EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194086EssentialsHENRY SCHEIN, INC.LZA2026-06-25
00050428426777CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLZA2026-06-24
00884389961196CURADMEDLINE INDUSTRIES, INC.LZA2026-06-23
00884389961202CURADMEDLINE INDUSTRIES, INC.LZA2026-06-23
00196633795946Kirkland SignatureCostco Wholesale CorporationLZA2026-06-17
00840546402292sunnycareAgio Group Inc.LZA2026-06-10
00840546402315sunnycareAgio Group Inc.LZA2026-06-10
00840546402339sunnycareAgio Group Inc.LZA2026-06-10
00840546402353sunnycareAgio Group Inc.LZA2026-06-10
00840546402377sunnycareAgio Group Inc.LZA2026-06-10
00840546402391sunnycareAgio Group Inc.LZA2026-06-10
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04