FDA.reportPublic FDA data

MocareHealth

Primary DI
16930518003013
Brand
MocareHealth
Company
Shanghai Motex Healthcare Co.,Ltd.
Model
6512WH90B
Device description
Polyisoprene Surgical Gloves, Powder-Free, Single Use, Sterile
Published
2022-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K123126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123126000MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)Shanghai Motex Healthcare Co., Ltd.2014-06-04KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16930518003013PackageGS150In Commercial Distribution
26930518003010PackageGS16In Commercial Distribution
06930518003016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693051800301316930518003013
2693051800301026930518003010
06930518003016069305180030166930518003016

GMDN Terms#

Term, Definition table
TermDefinition
Polyisoprene surgical glove, non-powdered, antimicrobialA device made of polyisoprene intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; it includes an antimicrobial or antiviral agent/properties to reduce viable-microbe exposure in case of sharp penetration and its inner surface is not covered with powder. It is used mainly as a two-way barrier to protect patient and staff from 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, elasticity) and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530438738
Device count
1
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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06930518036854MocareHealth7235802020-06-03
06930518002934MocareHealth6512WH55B2022-02-24
06930518002941MocareHealth6512WH60B2022-02-24
06930518002958MocareHealth6512WH65B2022-02-24
06930518002965MocareHealth6512WH70B2022-02-24
06930518002972MocareHealth6512WH75B2022-02-24
06930518002989MocareHealth6512WH80B2022-02-24
06930518002996MocareHealth6512WH85B2022-02-24
06930518003016MocareHealth6512WH90B2022-02-24
06930518003634MocareHealth6610GN55B2022-02-24
06930518003641MocareHealth6610GN60B2022-02-24
06930518003665MocareHealth6610GN65B2022-02-24
06930518003672MocareHealth6610GN70B2022-02-24
06930518003689MocareHealth6610GN75B2022-02-24
06930518003702MocareHealth6610GN80B2022-02-24
06930518003719MocareHealth6610GN85B2022-02-24
06930518003726MocareHealth6610GN90B2022-02-24
06930518032177MocareHealth1610ST852022-02-24
06930518032184MocareHealth1610ST902022-02-24
16930518002931MocareHealth6512WH55B2022-02-24

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