FDA.reportPublic FDA data

MocareHealth

Primary DI
26971384150040
Brand
MocareHealth
Company
Motex Healthcare(Anhui)Co.,Ltd.
Model
7235L
Device description
Single-Use Nitrile Examination Gloves
Published
2021-08-24
Public version status
Update
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
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030207000NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735Shanghai Motex Healthcare Co., Ltd.2003-05-02LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36971384150047PackageGS110Not in Commercial Distribution
26971384150040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3697138415004736971384150047
2697138415004026971384150040

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.

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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26971384150842MocareHealth1610/52021-08-26
26971384150859MocareHealth1610/5.52021-08-26
26971384150866MocareHealth1610/62021-08-26
26971384150873MocareHealth1610/6.52021-08-26
26971384150880MocareHealth1610/72021-08-26
26971384150897MocareHealth1610/7.52021-08-26
26971384150903MocareHealth1610/82021-08-26
26971384150910MocareHealth1610/8.52021-08-26
26971384150927MocareHealth1610/92021-08-26
26971384150934MocareHealth1610/9.52021-08-26
26971384150026MocareHealth7235S2021-08-24
26971384150057MocareHealth7235XL2021-08-24
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

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