The following data is part of a premarket notification filed by Goodgloves Industries Sdn Bhd with the FDA for Powder-free Nitrile Examination Glove, Non-sterile.
| Device ID | K221877 |
| 510k Number | K221877 |
| Device Name: | Powder-Free Nitrile Examination Glove, Non-Sterile |
| Classification | Polymer Patient Examination Glove |
| Applicant | GoodGloves Industries Sdn Bhd PT 12678, Jalan Techvalley 2, Sendayan Techvalley Bandar Sri Sendayan Seremban, MY 71950 |
| Contact | Yee Kam Lin |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-06-28 |
| Decision Date | 2022-07-23 |