SkinGard TPF LEGPPS

GUDID 09551023920017

Powdered Latex Examination Gloves Size: S

MARCON RUBBER INDUSTRY SDN BHD

Hevea-latex examination/treatment glove, powdered
Primary Device ID09551023920017
NIH Device Record Key0da581f2-689b-46e4-9383-3ea4a5b6923c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSkinGard TPF
Version Model NumberLEGPPS S
Catalog NumberLEGPPS
Company DUNS652593823
Company NameMARCON RUBBER INDUSTRY SDN BHD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109551023920017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYYLatex Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-03-26
Device Publish Date2023-12-20

On-Brand Devices [SkinGard TPF]

09555697506294Powdered Latex Examination Gloves Size: S
09555697506287Powdered Latex Examination Gloves Size: XS
09551023920017Powdered Latex Examination Gloves Size: S
09551023920000Powdered Latex Examination Gloves Size: XS
09551023920093Powder Free Latex Examination Gloves Size: XL
09551023920086Powder Free Latex Examination Gloves Size: L
09551023920079Powder Free Latex Examination Gloves Size: M
09551023920062Powder Free Latex Examination Gloves Size: S
09551023920055Powder Free Latex Examination Gloves Size: XS
09551023920048Powdered Latex Examination Gloves Size: XL
09551023920031Powdered Latex Examination Gloves Size: L
09551023920024Powdered Latex Examination Gloves Size: M

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