FDA.reportPublic FDA data

AG GLOVE

Primary DI
00860008313560
Brand
AG GLOVE
Company
ASIA GATE INTERNATIONAL SDN. BHD.
Model
NB444
Device description
Nitrile Examination Gloves Powder Free, Blue Colored, Non-Sterile, Size: L, 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
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
00860008313577PackageGS110In Commercial Distribution
00860008313560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008313577008600083135778600083135770860008313577
00860008313560008600083135608600083135600860008313560

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.

Contacts#

Phone, Email table
PhoneEmail
6307802948sales@shippyinc.com

Regulatory Flags#

DUNS number
659300918
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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
00860008313515AG GLOVENB1112022-08-01
00860008313539AG GLOVENB2222022-08-01
00860008313553AG GLOVENB3332022-08-01
00860008313577AG GLOVENB4442022-08-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03
10840064641262Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641279Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
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10840064641316Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641323Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641330Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641347Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641354Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
00199536000018BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZA2026-07-31