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 |