The following data is part of a premarket notification filed by Kossan International Sdn. Bhd. with the FDA for Sterile Powder Free Nitrile Examination Glove, Blue Colored, With Non-pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, With Non-pyrogenic Labeling Claim.
| Device ID | K191800 |
| 510k Number | K191800 |
| Device Name: | Sterile Powder Free Nitrile Examination Glove, Blue Colored, With Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, With Non-Pyrogenic Labeling Claim |
| 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 |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-03 |
| Decision Date | 2019-09-16 |