The following data is part of a premarket notification filed by Top Glove Sdn. Bhd. with the FDA for Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue.
| Device ID | K172923 |
| 510k Number | K172923 |
| Device Name: | Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue |
| Classification | Polymer Patient Examination Glove |
| Applicant | Top Glove Sdn. Bhd. Lot 4968, Jalan Teratai, Batu 6 Off Jalan Meru Klang, MY 41050 |
| Contact | Noor Akilah Binti Saidin |
| Correspondent | Noor Akilah Binti Saidin Top Glove Sdn. Bhd. Lot 4968, Jalan Teratai, Batu 6 Off Jalan Meru Klang, MY 41050 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-25 |
| Decision Date | 2018-04-26 |