The following data is part of a premarket notification filed by Worldmed Manufacturing Sdn. Bhd. with the FDA for Powder Free Natural Rubber Latex Examination Gloves.
| Device ID | K121844 |
| 510k Number | K121844 |
| Device Name: | POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | WORLDMED MANUFACTURING SDN. BHD. LOT 18873, JALAN PERUSAHAAN 3, KAMUNTING INDUSTRIAL ESTATE Kamunting, MY 34600 |
| Contact | Chandrasegaran |
| Correspondent | Chandrasegaran WORLDMED MANUFACTURING SDN. BHD. LOT 18873, JALAN PERUSAHAAN 3, KAMUNTING INDUSTRIAL ESTATE Kamunting, 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 | 2012-06-25 |
| Decision Date | 2013-09-06 |
| Summary: | summary |