FDA.reportPublic FDA data

Supmedic

Primary DI
00810160182955
Brand
Supmedic
Company
Supmedics Inc.
Model
SKF1302
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
K212578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212578000Nitrile disposable examination glovesXingyu Medical Tech Co., Ltd.2021-12-02LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810160182993PackageGS110In Commercial Distribution
00810160182955PrimaryGS10
00810160182757Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810160182993008101601829938101601829930810160182993
00810160182955008101601829558101601829550810160182955
00810160182757008101601827578101601827570810160182757

Regulatory Flags#

DUNS number
107150886
Device count
200
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049592413supmedicSKF13022025-05-15
00850049592420supmedicSKF13032025-05-15
00850049592437sup medicSKF13042025-05-15
00850049592444supmedicSKF13052025-05-15
00810160180005BEASTEKBTN14422024-11-04
00810160180012BEASTEKBTN14432024-11-04
00810160180043BeastekBTN24422024-10-02
00810160183549supUNE-XL-151052026-01-26
08101601833584supUNE-S-131022026-01-26
08101601833652supUNE-M-131032026-01-26
08101601833720supUNE-L-131042026-01-26
08101601833898supUNE-XL-131052026-01-26
08101601834338supUNE-S-141022026-01-26
08101601834406supUNE-M-141032026-01-26
08101601834574supUNE-L-141042026-01-26
08101601834642supUNE-XL-141052026-01-26
08101601835182supUNE-S-151022026-01-26
08101601835250supUNE-M-151032026-01-26
08101601835328supUNE-L-151042026-01-26
08101601835946supUNE-S-161022026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10840330701959ProCureTwin Med, LLCLYZ2026-05-27