FDA.report

Blue Sail

Primary DI
06973022280481
Brand
Blue Sail
Company
Shandong Blue Sail Innovation Co., Ltd.
Model
Vinyl Medical series
Device description
Disposable Vinyl Glove,Clear Color,Powdered,Size M
Published
2026-05-25
Public version status
New
Distribution status
Not 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
06973022280481PrimaryGS10
06973022280580Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06973022280481069730222804816973022280481
06973022280580069730222805806973022280580

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
421258413
Device count
100
DM exempt
false
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
true
Donation ID number
true
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06973022280153Blue SailVinyl Medical series2026-05-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06975219206540GcareZibo Blue Sail Innovation Co., Ltd.LYZ2026-05-26
06973022280153Blue SailShandong Blue Sail Innovation Co., Ltd.LYZ2026-05-25
40888277170897MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-03-20
40888277170972MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-03-20
40080196764076MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-25
40080196764083MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-25
40884389102221MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-25
40884389102238MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-25
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40080196167990MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
40080196168010MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
40888277305350MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
40888277305367MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
40888277305374MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-18
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
10810206691165BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691172BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691189BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691592BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691608BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691615BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691622BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691639BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10810206691646BasicBASIC MEDICAL TECHNOLOGY INC.LYZ2026-02-13
10193489136708MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
10193489136685MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11