The following data is part of a premarket notification filed by Eco Medi Glove Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove (blue) With Low Dermatitis Claim And With Tested For Use With Chemotherapy Drugs Claims.
| Device ID | K181066 |
| 510k Number | K181066 |
| Device Name: | Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Claim And With Tested For Use With Chemotherapy Drugs Claims |
| Classification | Polymer Patient Examination Glove |
| Applicant | ECO Medi Glove Sdn Bhd Lot 23826, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Perak, MY 34600 |
| Contact | Suresh Kumar |
| Correspondent | Suresh Kumar ECO Medi Glove Sdn Bhd Lot 23826, Jalan Tembaga Kuning Kamunting Raya Industrial Estate 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 | 2018-04-23 |
| Decision Date | 2018-09-26 |
| Summary: | summary |