FDA.reportPublic FDA data

MocareHealth

Primary DI
26971384153003
Brand
MocareHealth
Company
Motex Healthcare(Anhui)Co.,Ltd.
Model
2729F/8
Device description
Sterile Latex Powder-Free Surgical gloves
Published
2024-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K063757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063757000MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVESShanghai Motex Healthcare Co., Ltd.2007-07-27KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26971384153003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2697138415300326971384153003

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical 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 at the surgical site; 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 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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
560080502
Device count
1
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16971384154829MocareHealth7235-5.5/L2026-04-17
26971384154826MocareHealth7235-5.5/L2026-04-17
36971384154823MocareHealth7235-5.5/L2026-04-17
26971384150019MocareHealth7235XS2020-09-09
16971384153648MocareHealth7521F/52024-08-16
16971384153655MocareHealth7521F/5.52024-08-16
16971384153662MocareHealth7521F/62024-08-16
16971384153679MocareHealth7521F/6.52024-08-16
16971384153686MocareHealth7521F/72024-08-16
16971384153693MocareHealth7521F/7.52024-08-16
16971384153709MocareHealth7521F/82024-08-16
16971384153716MocareHealth7521F/8.52024-08-16
16971384153723MocareHealth7521F/92024-08-16
16971384153730MocareHealth7521F/9.52024-08-16
16971384153747MocareHealth7529F/52024-08-16
16971384153754MocareHealth7529F/5.52024-08-16
16971384153761MocareHealth7529F/62024-08-16
16971384153778MocareHealth7529F/6.52024-08-16
16971384153785MocareHealth7529F/72024-08-16
16971384153792MocareHealth7529F/7.52024-08-16

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