FDA.reportPublic FDA data

SUPERFIT

Primary DI
00814639023398
Brand
SUPERFIT
Company
APPLIED DENTAL, INC.
Model
A520-LTX70
Device description
SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 7.0.
Published
2020-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K151114000

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
K151114000Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with proteinSt. Marys Rubbers Pvt, Ltd.2015-12-11KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814639023395PackageGS150In Commercial Distribution
20814639023392PackageGS16In Commercial Distribution
30814639023399PackageGS14In Commercial Distribution
00814639023398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081463902339510814639023395
2081463902339220814639023392
3081463902339930814639023399
00814639023398008146390233988146390233980814639023398

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
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814639026856UNIFY Nylon Surgical SuturesXXS-N1012S7DXXS-N1012S7D2026-08-07
00814639026863UNIFY Nylon Surgical SuturesXXS-N1012S5DXXS-N1012S5D2026-08-07
00814639026962Premium UNIFY Fast Gut SuturesPXSRJ-618R11PXSRJ-618R112026-08-07
00814639026979Premium UNIFY Plain Gut SuturesPXSJ-618R11PXSJ-618R112026-08-07
00814639026993Premium UNIFY Plain Gut SuturesPXSJ-618R11DPXSJ-618R11D2026-08-07
00814639027006Premium UNIFY Plain Gut SuturesPSJ-518R13DPSJ-518R13D2026-08-07
00814639027013Premium UNIFY Plain Gut SuturesPSJ-418K13PSJ-418K132026-08-07
00814639027020Premium UNIFY Chromic SuturesPSC-518R13DPSC-518R13D2026-08-07
00814639027037Premium UNIFY Chromic Gut SuturesPXSC-618R11PXSC-618R112026-08-07
00814639027044Premium UNIFY Chromic Gut SuturesPXSC-618R11DPXSC-618R11D2026-08-07
00814639027051Premium UNIFY Chromic SuturesPSC-418R13DPSC-418R13D2026-08-07
00814639025606UNIFY PGA Surgical SuturesS-G518XR13-U2026-07-17
00814639025781UNIFY PGA Surgical SuturesS-G518XR13-U2023-04-12
00814639023374SUPERFITA520-LTX602020-08-06
00814639023381SUPERFITA520-LTX652020-08-06
00814639023404SUPERFITA520-LTX752020-08-06
00814639023411SUPERFITA520-LTX802020-08-06
00814639026832UNIFY MicroSutures SilkXXS-S618S6DXXS-S618S6D2026-04-27
00814639026849UNIFY MicroSutures SilkXS-S618R11DXS-S618R11D2026-04-27
00814639021615UNIFY PGA Surgical SuturesXS-G618R11-U2015-08-21

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