FDA.reportPublic FDA data

SUPERFIT

Primary DI
00814639023404
Brand
SUPERFIT
Company
APPLIED DENTAL, INC.
Model
A520-LTX75
Device description
SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 7.5.
Published
2020-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10814639023401PackageGS150In Commercial Distribution
20814639023408PackageGS16In Commercial Distribution
00814639023404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081463902340110814639023401
2081463902340820814639023408
00814639023404008146390234048146390234040814639023404

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powdered, antimicrobialA device containing Hevea natural rubber latex (NRL) [e.g., NRL/polymer composite] 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 intended 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 both the patient and the staff against contamination. 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.

Contacts#

Phone, Email table
PhoneEmail
1-888-841-8481info.usa@AD-Surgical.com

Regulatory Flags#

DUNS number
017524666
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
00814639026832UNIFY MicroSutures SilkXXS-S618S6DXXS-S618S6D2026-04-27
00814639026849UNIFY MicroSutures SilkXS-S618R11DXS-S618R11D2026-04-27
00814639021615UNIFY PGA Surgical SuturesXS-G618R11-U2015-08-21
00814639021622UNIFY PGA Surgical SuturesXS-G718R112015-08-21
00814639021660UNIFY Nylon Surgical SuturesXXS-N1012S6D2015-08-21
00814639021677UNIFY Nylon Surgical SuturesXXS-N807T62015-08-21
00814639021950Premium UNIFY PP SuturesPSP-518R132015-08-21
00814639021967Premium UNIFY Polypropylene SuturesPSP-618R132015-08-21
00814639022414Premium UNIFY PP SuturesPMP-518R192016-11-09
00814639022421Premium UNIFY PP SuturesPMP-418R192016-11-09
00814639022438Premium UNIFY PP SuturesPSP-418R132016-11-09
00814639022803Premium UNIFY PP SuturesPMP-418R162016-11-09
00814639023602UNIFY Nylon Surgical SuturesXXS-N1007S62017-08-02
00814639023732Premium UNIFY PP SuturesPLP-427R242020-08-03
00814639023749Premium UNIFY PP SuturesPLP-327R242020-08-03
00814639024135UNIFY Nylon Surgical SuturesXXS-N905T52020-07-30
00814639024142UNIFY Nylon Surgical SuturesXXS-N1005T42020-07-30
00814639024791Premium UNIFY PP SuturesPMP-318R192020-08-03
00814639025538UNIFY PGCL Surgical SuturesXS-Q518R112021-04-23
00814639025545UNIFY PGCL Surgical SuturesXS-Q518R11-C2021-04-23

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