FDA.reportPublic FDA data

Adenna

Primary DI
10653195009982
Brand
Adenna
Company
ADENNA LLC
Model
VTX998
Catalog number
VTX998
Device description
Adenna® Disposable Vinyl Exam Grade Gloves, Powder Free, Clear, 3.9 mil, Ex-Large, 90/bx, 10 bxs/cs
Published
2020-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072228000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072228000SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)Pinnacle Co., Ltd.2008-02-08LYZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653195009982PackageGS110In Commercial Distribution
00653195009985PrimaryGS10
70653195009984Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065319500998210653195009982
00653195009985006531950099856531950099850653195009985
7065319500998470653195009984

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8003219832info@hospeco.com

Regulatory Flags#

DUNS number
112042723
Device count
90
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00653195737703PrecisionPCS770PCS7702020-04-20
00653195737727PrecisionPCS772PCS7722020-04-20
00653195737758PrecisionPCS775PCS7752020-04-20
00653195737765PrecisionPCS776PCS7762020-04-20
00653195737789PrecisionPCS778PCS7782020-04-20
00653195002207Night AngelNGL220NGL2202020-04-22
00653195002221AdennaNGL222NGL2222020-04-20
00653195002252Night AngelNGL225NGL2252020-04-20
00653195002269Night AngelNGL226NGL2262020-04-17
00653195002283Night AngelNGL228NGL2282020-04-20
00653195002306AdennaVPF230VPF2302020-04-20
00653195002320AdennaVPF232VPF2322020-04-20
00653195002351AdennaVPF235VPF2352020-04-20
00653195002368AdennaVPF236VPF2362020-04-20
00653195002382AdennaVPF238VPF2382020-04-20
00653195002603AdennaGLD260GLD2602020-04-17
00653195002627AdennaGLD262GLD2622020-04-17
00653195002658AdennaGLD265GLD2652020-04-17
00653195002665AdennaGLD266GLD2662020-04-17
00653195002689AdennaGLD268GLD2682020-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810160182955SupmedicSupmedics Inc.LYZ2026-11-05
00884389108393CURADMEDLINE INDUSTRIES, INC.LYZ2026-10-29
00199536905610BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905627BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905634BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905641BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905658BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00850084857218MedClickMedClick LLCLYZ2026-07-22
00850084857225MedClickMedClick LLCLYZ2026-07-22
00850084857232MedClickMedClick LLCLYZ2026-07-22
00850084857249MedClickMedClick LLCLYZ2026-07-22
00850084857256MedClickMedClick LLCLYZ2026-07-22
00850084857263MedClickMedClick LLCLYZ2026-07-22
00850084857270MedClickMedClick LLCLYZ2026-07-22
00850084857287MedClickMedClick LLCLYZ2026-07-22
00850084857294MedClickMedClick LLCLYZ2026-07-22
00850084857300MedClickMedClick LLCLYZ2026-07-22
00850084857317MedClickMedClick LLCLYZ2026-07-22
00850084857324MedClickMedClick LLCLYZ2026-07-22
00080196515939CURADMEDLINE INDUSTRIES, INC.LYZ2026-07-06
00810145952054NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952061NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952078NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952085NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952092NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00713733712835MeijerMEIJER, INC.LYZ2026-06-05
10840330701911ProCureTwin Med, LLCLYZ2026-05-27
10840330701928ProCureTwin Med, LLCLYZ2026-05-27
10840330701935ProCureTwin Med, LLCLYZ2026-05-27
10840330701942ProCureTwin Med, LLCLYZ2026-05-27