Annuy Powder-free Latex Patient Examination Glove

Primary DI
26928965100024
Brand
Annuy Powder-free Latex Patient Examination Glove
Company
Anhui Annuy Latex Products Co.,Ltd.
Model
M
Device description
A non-sterile device made of natural latex intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes.
Published
2021-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LYYLatex Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150612000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150612000Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free)Anhui Anyu Latex Products Co., Ltd.2015-11-16LYY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26928965100024PackageGS110In Commercial Distribution
16928965100027PrimaryGS10
06928965100020Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2692896510002426928965100024
1692896510002716928965100027
06928965100020069289651000206928965100020

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421347466
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16928965100010Annuy Powder-free Latex Patient Examination GloveS2021-01-26
16928965100027Annuy Powder-free Latex Patient Examination GloveM2021-01-26
16928965100034Annuy Powder-free Latex Patient Examination GloveL2021-01-26
16928965100041Annuy Powder-free Nitrile Patient Examination GloveS2021-01-26
16928965100058Annuy Powder-free Nitrile Patient Examination GloveM2021-01-26
16928965100065Annuy Powder-free Nitrile Patient Examination GloveL2021-01-26
26928965100017Annuy Powder-free Latex Patient Examination GloveS2021-01-26
26928965100031Annuy Powder-free Latex Patient Examination GloveL2021-01-26
26928965100048Annuy Powder-free Nitrile Patient Examination GloveS2021-01-26
26928965100055Annuy Powder-free Nitrile Patient Examination GloveM2021-01-26
06928965100068Annuy Powder-free Nitrile Patient Examination GloveL2021-01-26

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