FDA.reportPublic FDA data

MEDADV

Primary DI
10819667020064
Brand
MEDADV
Company
MEDAS INC
Model
M711
Catalog number
M711
Device description
LATEX SURGICAL GLOVES - POWDER FREE 6.5
Published
2018-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
20819667020061PackageGS16In Commercial Distribution
10819667020064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081966702006120819667020061
1081966702006410819667020064

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity

Contacts#

Phone, Email table
PhoneEmail
+1 (786) 7870396customerservice@medasusa.com

Regulatory Flags#

DUNS number
080593067
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819667020746MEDADVM95F61135JM95F61135J2018-04-09
00819667020753MEDADVM95R50721SM95R0721S2018-04-09
00819667020784MEDADVM962P0SM962P0S2018-04-11
00819667020791MEDADVM962P20XLM962P20XL2018-04-11
00819667020807MEDADVM962P20M962P202018-04-11
00819667020814MEDADVM962P20LM962P20L2018-04-11
00819667020647MEDADVM93135150AM93135150A2018-04-11
00819667020654MEDADVM93135260AM93135260A2018-04-09
00819667020166MEDADVM101M1012018-04-12
00819667020982MEDADVM507M5072018-04-11
00819667020258MEDADVM209M2092018-04-10
00819667020265MEDADVM206M2062018-04-11
00819667020272MEDADVM207M2072018-04-10
00819667020289MEDADVM210M2102018-04-09
10819667020071MEDADVM712M7122018-03-01
10819667020088MEDADVM713M7132018-03-01
10819667020095MEDADVM714M7142018-03-01
10819667020101MEDADVM716M7162018-03-01
10819667020118MEDADVM717M7172018-03-01
00819667020043MEDADVM705M7052018-01-09

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Primary DI, Brand, Company table
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