The following data is part of a premarket notification filed by Smart Glove Corporation Sdn.bhd. with the FDA for Powder-free Green Biodegradable Nitrile Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl Citrate.
| Device ID | K213373 |
| 510k Number | K213373 |
| Device Name: | Powder-Free Green Biodegradable Nitrile Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
| Classification | Polymer Patient Examination Glove |
| Applicant | Smart Glove Corporation Sdn.Bhd. Lot 6487, Batu 5 3/4 Sementa, Jalan Kapar Klang, MY 42100 |
| Contact | Lim Chin Keong |
| Correspondent | Lim Chin Keong Smart Glove Corporation Sdn.Bhd. Lot 6487, Batu 5 3/4 Sementa, Jalan Kapar Klang, MY 42100 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-12 |
| Decision Date | 2022-03-10 |