FDA.reportPublic FDA data

BASIC

Primary DI
B845NGXM10453
Brand
BASIC
Company
Intco Medical Industries, Inc.
Model
NGXM1045
Published
2023-06-09
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
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123869000
K133307000
K232252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123869000POWDER-FREE NITRILE PATIENT EXAMINATION GLOVESDehai (Shandong) Medical Gloves, Co., Ltd.2013-02-28LZA
K133307000
K232252000Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)Dehai (Shandong) Medical Gloves, Co., Ltd.2023-11-28LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B845NGXM10453PackageHIBCC10In Commercial Distribution
B845NGXM10451PrimaryHIBCC0
B845NGXM1045Unit of UseHIBCC0

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
+862134978818maxli@intco.com

Regulatory Flags#

DUNS number
080162537
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
B845FM301A501BASICFM301A502024-06-14
B845X1021WOTUREX1022025-08-20
B845X1023WOTUREX1022025-08-20
B845X3011WOTUREX3012025-06-13
B845X3021WOTUREX3022025-06-13
B845X3013WOTUREX3012025-06-13
B845X3023WOTUREX3022025-06-13
B845FM301A50K1BASICFM301A50K2025-04-30
B845FM301A50W1BASICFM301A50W2025-04-30
B845FM301A50K3BASICFM301A50K2025-04-30
B845FM301A50W3BASICFM301A50W2025-04-30
B845CBZ0411WOTURECBZ0412025-03-28
B845CBZ0413WOTURECBZ0412025-03-28
B845CBZ041WOTURECBZ042025-03-20
B845NGPF201C31BASICNGPF201C3NGPF201C32024-09-28
B845NGPF201C41BASICNGPF201C4NGPF201C42024-09-28
B845NGPF201C51BASICNGPF201C5NGPF201C52024-09-28
B845NGPF201C61BASICNGPF201C6NGPF201C62024-09-28
B845NGPF201C71BASICNGPF201C7NGPF201C72024-09-28
B845NGPF201C81BASICNGPF201C8NGPF201C82024-09-28

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00850084857393MedClickMedClick LLCLZA2026-07-22
00850084857409MedClickMedClick LLCLZA2026-07-22
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
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00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
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