FDA.reportPublic FDA data

TACKLE

Primary DI
05060887690614
Brand
TACKLE
Company
Tackle
Model
Black Nitrile XL Size 50PCS
Published
2024-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
15060887690611PackageGS120In Commercial Distribution
05060887690614PrimaryGS10
35060887690615Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506088769061115060887690611
05060887690614050608876906145060887690614
3506088769061535060887690615

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.

Regulatory Flags#

DUNS number
104622818
Device count
50
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060887690522TACKLEBlack Nitrile XL Size 100PCS2023-07-31
05060887690539TACKLEBlack Nitrile L Size 100PCS2023-07-31
05060887690546TACKLEBlack Nitrile L Size 50PCS2023-07-31
05060887690553TACKLEBlue Nitrile S Size 100PCS2023-07-31
05060887690560TACKLEBlue Nitrile M Size 100PCS2023-07-31
05060887690577TACKLEBlue Nitrile L Size 100PCS2023-07-31
05060887690584TACKLEBlue Nitrile XL Size 100PCS2023-07-31
15060887690611TACKLEBlack Nitrile XL Size 50PCS2024-01-05
15060887690529TACKLEBlack Nitrile XL Size 100PCS2023-07-31
15060887690536TACKLEBlack Nitrile L Size 100PCS2023-07-31
15060887690543TACKLEBlack Nitrile L Size 50PCS2023-07-31
35060887690554TACKLEBlue Nitrile S Size 100PCS2023-07-31
15060887690567TACKLEBlue Nitrile M Size 100PCS2023-07-31
15060887690574TACKLEBlue Nitrile L Size 100PCS2023-07-31
15060887690581TACKLEBlue Nitrile XL Size 100PCS2023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10840064641286Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641293Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641309Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
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
00199536000032BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000049BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000056BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00366975065506Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065513Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065520Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065537Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00860010400906LuvatekR&C Imports LLCLZA2026-07-29
00860010400920LuvatekR&C Imports LLCLZA2026-07-29
00860010400937LuvatekR&C Imports LLCLZA2026-07-29
00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22