FDA.reportPublic FDA data

Violet Pearl Nitrile

Primary DI
05060264110094
Brand
Violet Pearl Nitrile
Company
Ug Healthcare (usa), Inc.
Model
GP0075
Device description
Violet nitrile gloves - medical grade - size XL
Published
2026-07-20
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

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
05060264110094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060264110094050602641100945060264110094

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
621428051
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
05060264110056Violet Pearl NitrileGP00712026-07-20
05060264110063Violet Pearl NitrileGP00722026-07-20
05060264110070Violet Pearl NitrileGP00732026-07-20
05060264110087Violet Pearl NitrileGP00742026-07-20
00721573000418Black Pearl NitrileGP00312024-01-17
00721573000425Black Pearl NitrileGP00322024-01-17
00721573000432Black Pearl NitrileGP00332024-01-17
00721573000449Black Pearl NitrileGP00342024-01-17
00721573000456Black Pearl NitrileGP00352024-01-17
00721573000906Pro.Tect Black NitrileGA00422024-01-17
00721573000913Pro.Tect Black NitrileGA00432024-01-17
00721573000920Pro.Tect Black NitrileGA00442024-01-17
00721573000937Pro.Tect Black NitrileGA00452024-01-17
00721573001347Rose Pearl NitrileGP00512025-05-02
00721573001354Rose Pearl NitrileGP00522025-05-02
00721573001361Rose Pearl NitrileGP00532025-05-02
00721573001378Rose Pearl NitrileGP00542025-05-02
00721573001385Rose Pearl NitrileGP00552025-05-02
05060264114597UnicareGS00412025-05-02
05060264114603UnicareGS00422025-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199536900851BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
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
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