FDA.reportPublic FDA data

SHINEMOUND ENTERPRISE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12219211221921SHINEMOUND ENTERPRISE, INC.1Y2026-01-0119 Sterling Rd Ste 6A N Billerica MA US 01862

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
307151766688017K994258SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVESLYZ2000-01-20
307151692050892K994248SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVESLYZ2000-01-28
307151951779615K993240SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVESLYZ1999-10-27
307151542871949K993231SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVESLYZ1999-10-27
307151650871670K972104LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVESLYZ1997-08-15
307151107552236K971360SYNTEXLYZ1997-12-22
307151039133849K970625POLY-MEDLYY1997-03-27
307152028786521K051913POWDERED LATEX PATIENT EXAMINATION GLOVESLYY2005-09-30
307151371817855
307151444489660
307151351385762
307151620274844

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LYZ62000-01-28
LYY22005-09-30

PMN#

SYNTEX

1997-12-22

SHINEMOUND ENTERPRISE, INC.

POLY-MED

1997-03-27

SHINEMOUND ENTERPRISE, INC.