FDA.reportPublic FDA data

GP CRAFT

Primary DI
00810120950617
Brand
GP CRAFT
Company
Diamond Gloves
Model
GP2004
Device description
BLACK NITRILE EXAM GLOVES, X-LARGE
Published
2023-02-09
Public version status
New
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
00810120950624PackageGS110In Commercial Distribution
00810120950617PrimaryGS10
00810120950600Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810120950624008101209506248101209506240810120950624
00810120950617008101209506178101209506170810120950617
00810120950600008101209506008101209506000810120950600

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
052262122
Device count
100
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810120952253ADVANCE IF 36BPF-36XS2025-05-30
00810120952284ADVANCE IF 36BPF-36S2025-05-30
00810120952314ADVANCE IF 36BPF-36M2025-05-30
00810120952345ADVANCE IF 36BPF-36L2025-05-30
00810120952376ADVANCE IF 36BPF-36XL2025-05-30
00810120952406ADVANCE IF 36BPF-36XXL2025-05-30
00810120952437ADVANCE IF 42BPF-42M2025-07-01
00810120952468ADVANCE IF 42BPF-42XS2025-07-01
00810120952499ADVANCE IF 42BPF-42S2025-07-01
00810120952529ADVANCE IF 42BPF-42L2025-07-01
00810120952550ADVANCE IF 42BPF-42XL2025-07-01
00810120952581ADVANCE IF 42BPF-42XXL2025-07-01
00810120952444ADVANCE IF 42BPF-42M2025-07-01
00810120952475ADVANCE IF 42BPF-42XS2025-07-01
00810120952505ADVANCE IF 42BPF-42S2025-07-01
00810120952536ADVANCE IF 42BPF-42L2025-07-01
00810120952567ADVANCE IF 42BPF-42XL2025-07-01
00810120952598ADVANCE IF 42BPF-42XXL2025-07-01
00810120952260ADVANCE IF 36BPF-36XS2025-05-30
00810120952420ADVANCE IF 36BPF-36S2025-05-30

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