FDA.reportPublic FDA data

AG GLOVE

Primary DI
00860008313515
Brand
AG GLOVE
Company
ASIA GATE INTERNATIONAL SDN. BHD.
Model
NB111
Device description
Nitrile Examination Gloves Powder Free, Blue Colored, Non-Sterile, Size: XS, QTY: 100 PCS Gloves by weight, MADE IN MALAYSIA
Published
2022-08-01
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008313515PackageGS110In Commercial Distribution
00860008313508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008313515008600083135158600083135150860008313515
00860008313508008600083135088600083135080860008313508

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, 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; it includes an antimicrobial or antiviral agent/properties to reduce viable-microbe transmission/exposure and its inner surface is not covered with powder. 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6307802948sales@shippyinc.com

Regulatory Flags#

DUNS number
659300918
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008313584AG GLOVENB3332023-01-19
00860008313508AG GLOVENB1112022-08-01
00860008313522AG GLOVENB2222022-08-01
00860008313546AG GLOVENB3332022-08-01
00860008313560AG GLOVENB4442022-08-01
00860008313539AG GLOVENB2222022-08-01
00860008313553AG GLOVENB3332022-08-01
00860008313577AG GLOVENB4442022-08-01

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Primary DI, Brand, Company table
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00199536000018BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
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