FDA.report

Gcare

Primary DI
06975219206540
Brand
Gcare
Company
Zibo Blue Sail Innovation Co., Ltd.
Model
479.801
Device description
Disposable Vinyl Glove,Clear Colour,Powder Free,M 4.5g,Size XL
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06975219206540PrimaryGS10
06975219206526Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06975219206540069752192065406975219206540
06975219206526069752192065266975219206526

GMDN Terms

TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
621646344
Device count
200
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DIBrandModelCatalogPublished
06975219206298RhesusNT3001-2002026-05-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06973022280153Blue SailShandong Blue Sail Innovation Co., Ltd.LYZ2026-05-25
06973022280481Blue SailShandong Blue Sail Innovation Co., Ltd.LYZ2026-05-25
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40884389102238MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-25
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40080196167990MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
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40888277305381MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
10810206690953BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206690960BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206690977BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691158BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
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10810206691646BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10193489136708MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
10193489136685MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11