The following data is part of a premarket notification filed by Lalan Rubbers (pvt) Ltd with the FDA for Nitrile Patient Examination Gloves, Powder Free.
| Device ID | K220697 |
| 510k Number | K220697 |
| Device Name: | Nitrile Patient Examination Gloves, Powder Free |
| Classification | Polymer Patient Examination Glove |
| Applicant | Lalan Rubbers (Pvt) Ltd No.95/B, Zone A, Export Processing Zone, Biyagama Malwana, LK EPZ 11672 |
| Contact | Renuka Priyangi |
| Correspondent | Renuka Priyangi Lalan Rubbers (Pvt) Ltd No.95/B, Zone A, Export Processing Zone, Biyagama Malwana, LK EPZ 11672 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-09 |
| Decision Date | 2022-09-15 |