FDA.reportPublic FDA data

Black Pearl Nitrile

Primary DI
00721573000432
Brand
Black Pearl Nitrile
Company
Ug Healthcare (usa), Inc.
Model
GP0033
Device description
Black nitrile gloves - medical grade - size Medium
Published
2024-01-17
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182528000Nitrile Glove Powder Free BlackHaining Medical Products Co., Ltd.2018-11-15LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00721573000432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00721573000432007215730004327215730004320721573000432

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

Regulatory Flags#

DUNS number
621428051
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00721573000418Black Pearl NitrileGP00312024-01-17
00721573000425Black Pearl NitrileGP00322024-01-17
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
05060264114610UnicareGS00432025-05-02
05060264114627UnicareGS00442025-05-02
05060264114634UnicareGS00452025-05-02
00721573000814Lucky Supply Black LatexLBGXS2023-06-30
00721573000821Lucky Supply Black LatexLBGS2023-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
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10840330702239ProCureTwin Med, LLCLZA2026-06-01
10840330702246ProCureTwin Med, LLCLZA2026-06-01
10840330706756ProCureTwin Med, LLCLZA2026-06-01
10840330706763ProCureTwin Med, LLCLZA2026-06-01
10840330706770ProCureTwin Med, LLCLZA2026-06-01
10840330706787ProCureTwin Med, LLCLZA2026-06-01