FDA.reportPublic FDA data

HS Glove

Primary DI
09551012690006
Brand
HS Glove
Company
HONG SENG GLOVES SDN. BHD.
Model
A035RGB240F (XS)
Device description
Powder Free Nitrile Examination Glove
Published
2023-05-08
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
K212804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212804000Powder free nitrile examination glove- blue, non-sterileHong Seng Gloves Sdn Bhd2021-12-01LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09551012690006PrimaryGS10
09551012690600Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09551012690006095510126900069551012690006
09551012690600095510126906009551012690600

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00Keep dry.
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
659302353
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09551012690013HS GloveA035RGB240F (S)2023-05-08
09551012690020HS GloveA035RGB240F (M)2023-05-08
09551012690037HS GloveA035RGB240F (L)2023-05-08
09551012690044HS GloveA035RGB240F (XL)2023-05-08
09551012690051HS GloveA035RGB240F (XXL)2023-05-08
09551012690068HS GloveA035BLK240F (XS)2023-05-08
09551012690075HS GloveA035BLK240F (S)2023-05-08
09551012690082HS GloveA035BLK240F (M)2023-05-08
09551012690099HS GloveA035BLK240F (L)2023-05-08
09551012690105HS GloveA035BLK240F (XL)2023-05-08
09551012690112HS GloveA035BLK240F (XXL)2023-05-08
09551012690129HS GloveA035WHT240F (XS)2023-05-08
09551012690136HS GloveA035WHT240F (S)2023-05-08
09551012690143HS GloveA035WHT240F (M)2023-05-08
09551012690150HS GloveA035WHT240F (L)2023-05-08
09551012690167HS GloveA035WHT240F (XL)2023-05-08
09551012690174HS GloveA035WHT240F (XXL)2023-05-08

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