FDA.reportPublic FDA data

BASIC

Primary DI
B845NGPF201C31
Brand
BASIC
Company
Intco Medical Industries, Inc.
Model
NGPF201C3
Catalog number
NGPF201C3
Device description
Synguard Nitrile Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Published
2024-09-28
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
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233598000Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other DrugsAnhui Intco Medical Products Co., Ltd.2024-01-26LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B845NGPF201C33PackageHIBCC10In Commercial Distribution
B845NGPF201C31PrimaryHIBCC0
B845NGPF201C3Unit 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.

Contacts#

Phone, Email table
PhoneEmail
+862134978818maxli@intco.com

Regulatory Flags#

DUNS number
080162537
Device count
200

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
B845NGPF201C41BASICNGPF201C4NGPF201C42024-09-28
B845NGPF201C51BASICNGPF201C5NGPF201C52024-09-28
B845NGPF201C61BASICNGPF201C6NGPF201C62024-09-28
B845NGPF201C71BASICNGPF201C7NGPF201C72024-09-28
B845NGPF201C81BASICNGPF201C8NGPF201C82024-09-28
B845NGPF203C31BASICNGPF203C3NGPF203C32024-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22
00850084857362MedClickMedClick LLCLZA2026-07-22
00850084857379MedClickMedClick LLCLZA2026-07-22
00850084857386MedClickMedClick LLCLZA2026-07-22
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
00850005229803NeulynxMedgluv Inc.OPJ2026-07-17
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229803NeulynxMedgluv Inc.QDO2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.QDO2026-07-17
00850005229810NeulynxMedgluv Inc.OPJ2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.QDO2026-07-17
00850005229827NeulynxMedgluv Inc.OPJ2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.OPJ2026-07-17
00850005229834NeulynxMedgluv Inc.QDO2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.QDO2026-07-17
00850005229841NeulynxMedgluv Inc.OPJ2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.QDO2026-07-14
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZC2026-07-14