MEDTEXX
Latex Patient Examination Glove
REGALFIELD SDN. BHD.
The following data is part of a premarket notification filed by Regalfield Sdn. Bhd. with the FDA for Medtexx.
Pre-market Notification Details
| Device ID | K963331 |
| 510k Number | K963331 |
| Device Name: | MEDTEXX |
| Classification | Latex Patient Examination Glove |
| Applicant | REGALFIELD SDN. BHD. PT 5054, KAMUNTING INDUSTRIAL ESTATE, P.O. BOX 9, KAMUNTING Taiping, Perak, MY 34600 |
| Contact | Low Bok Tek |
| Correspondent | Low Bok Tek REGALFIELD SDN. BHD. PT 5054, KAMUNTING INDUSTRIAL ESTATE, P.O. BOX 9, KAMUNTING Taiping, Perak, MY 34600 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-23 |
| Decision Date | 1997-01-24 |
Trademark Results [MEDTEXX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDTEXX 78840455 3550270 Dead/Cancelled |
AQL MEDICAL SDN. BHD. 2006-03-17 |
 MEDTEXX 78840393 not registered Dead/Abandoned |
Jaya Medical Supplies, Inc. 2006-03-17 |
 MEDTEXX 77567228 not registered Dead/Abandoned |
Jaya Medical Supplies, Inc. 2008-09-10 |
 MEDTEXX 74595313 2018211 Dead/Cancelled |
AQL MEDICAL SDN. BHD. 1994-11-04 |
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