The following data is part of a premarket notification filed by Eco Medi Glove Sdn. Bhd. with the FDA for Emg Powder Free Nitrile Examination Glove (blue) With Peppermint Scented.
Device ID | K152937 |
510k Number | K152937 |
Device Name: | EMG Powder Free Nitrile Examination Glove (Blue) With Peppermint Scented |
Classification | Polymer Patient Examination Glove |
Applicant | ECO MEDI GLOVE SDN. BHD. LOT 23826, JALAN TEMBAGA KUNING, KAMUNTING RAYA INDUSTRIAL ESTATE Kumunting Perak, MY 34600 |
Contact | Suresh Kumar |
Correspondent | Suresh Kumar ECO MEDI GLOVE SDN. BHD. LOT 23826, JALAN TEMBAGA KUNING, KAMUNTING RAYA INDUSTRIAL ESTATE Kumunting Perak, MY 34600 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-10-05 |
Decision Date | 2016-06-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10304040057008 | K152937 | 000 |
H658103330124 | K152937 | 000 |
H658103330225 | K152937 | 000 |
H658103330326 | K152937 | 000 |
H658103334128 | K152937 | 000 |
10304040056964 | K152937 | 000 |
10304040056971 | K152937 | 000 |
10304040056988 | K152937 | 000 |
10304040056995 | K152937 | 000 |
H658103330023 | K152937 | 000 |