FDA.reportPublic FDA data

Snow Lotus

Primary DI
06936610210277
Brand
Snow Lotus
Company
Beijing Reagent Latex Products Factory
Model
7.5
Device description
Powdered Sterile Latex Surgical Gloves
Published
2021-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062797000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062797000POWDERED LATEX SURGICAL GLOVEBeijing Reagent Latex Products Co., Ltd.2007-04-11KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936610210274PackageGS150In Commercial Distribution
26936610210271PackageGS18In Commercial Distribution
06936610210277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693661021027416936610210274
2693661021027126936610210271
06936610210277069366102102776936610210277

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, powderedA sterile device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is covered with talcum powder primarily to facilitate donning and removal; it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Regulatory Flags#

DUNS number
653865840
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936610210017Snow LotusXXS2021-09-18
06936610210024Snow LotusXS2021-09-18
06936610210031Snow LotusS2021-09-18
06936610210048Snow LotusM2021-09-18
06936610210055Snow LotusL2021-09-18
06936610210062Snow LotusXL2021-09-18
06936610210079Snow LotusXXS2021-09-18
06936610210086Snow LotusXS2021-09-18
06936610210093Snow LotusS2021-09-18
06936610210109Snow LotusM2021-09-18
06936610210116Snow LotusL2021-09-18
06936610210123Snow LotusXL2021-09-18
06936610210130Snow LotusXXL2021-09-18
06936610210154Snow Lotus62021-09-18
06936610210161Snow Lotus6.52021-09-18
06936610210178Snow Lotus72021-09-18
06936610210185Snow Lotus7.52021-09-18
06936610210192Snow Lotus82021-09-18
06936610210208Snow Lotus8.52021-09-18
06936610210215Snow Lotus92021-09-18

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Primary DI, Brand, Company table
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