The following data is part of a premarket notification filed by Kossan International Sdn. Bhd. with the FDA for Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Tested For Use With Chemotherapy Drugs A.
| Device ID | K183287 |
| 510k Number | K183287 |
| Device Name: | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested For Use With Chemotherapy Drugs A |
| Classification | Polymer Patient Examination Glove |
| Applicant | Kossan International Sdn. Bhd. Wisma Kossan, Lot 782, Jalan Sungai Putus Off Batu 3 3/4, Jalan Kapar Klang, MY 42100 |
| Contact | Cho Sow Fong |
| Correspondent | Cho Sow Fong Kossan International Sdn. Bhd. Wisma Kossan, Lot 782, Jalan Sungai Putus Off Batu 3 3/4, 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 | 2018-11-26 |
| Decision Date | 2019-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850044458004 | K183287 | 000 |
| 10850044458131 | K183287 | 000 |
| 10850044458124 | K183287 | 000 |
| 10850044458117 | K183287 | 000 |
| 10850044458100 | K183287 | 000 |
| 10850044458094 | K183287 | 000 |