The following data is part of a premarket notification filed by Worldmed Manufacturing Sdn. Bhd. with the FDA for Chlorinated Powder Free Nitrile Examination Gloves (black Colour).
| Device ID | K123116 |
| 510k Number | K123116 |
| Device Name: | CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) |
| Classification | Polymer Patient Examination Glove |
| Applicant | WORLDMED MANUFACTURING SDN. BHD. Lot 18873, Jalan Perusahaan3, Kamunting Industrial Estate, Kamunting Kamunting, MY 34600 |
| Contact | Ooi Loon Seng |
| Correspondent | Ooi Loon Seng WORLDMED MANUFACTURING SDN. BHD. Lot 18873, Jalan Perusahaan3, Kamunting Industrial Estate, Kamunting Kamunting, 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 | 2012-10-03 |
| Decision Date | 2013-02-11 |
| Summary: | summary |