FDA.reportPublic FDA data

MocareHealth

Primary DI
36971384150849
Brand
MocareHealth
Company
Motex Healthcare(Anhui)Co.,Ltd.
Model
1610/5
Device description
Single-use sterile rubber surgical gloves
Published
2021-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
36971384150849PackageGS16In Commercial Distribution
26971384150842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3697138415084936971384150849
2697138415084226971384150842

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
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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