The following data is part of a premarket notification filed by Kgm Gloves Sdn. Bhd. with the FDA for Powder Free Nitrile Examination Gloves (blue).
| Device ID | K220284 |
| 510k Number | K220284 |
| Device Name: | Powder Free Nitrile Examination Gloves (Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | KGM Gloves Sdn. Bhd. Lot 18893 & 18894, Jalan Perusahaan 9, Kawasan Perusahaan Kamunting, MY 34600 |
| Contact | Ooi Loon Seng |
| Correspondent | Ooi Loon Seng KGM Gloves Sdn. Bhd. Lot 18893 & 18894, Jalan Perusahaan 9, Kawasan Perusahaan 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 | 2022-02-01 |
| Decision Date | 2022-07-08 |