FDA.reportPublic FDA data

AdvanCare

Primary DI
B845ANBM100141
Brand
AdvanCare
Company
Intco Medical Industries, Inc.
Model
ANBM10014
Catalog number
ANBM10014
Device description
AdvanCare Dispoable Nitrile Exam Gloves
Published
2022-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170136000Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Feiyang Professional Gloves Co., Ltd.2017-08-25LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B845ANBM100143PackageHIBCC10In Commercial Distribution
B845ANBM100141PrimaryHIBCC0
B845ANBM10014Unit 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
No natural rubber latex
true

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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