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, Polymer Coated, Tested For Use With Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Polymer Coated, Tested For Use With Chemother.
| Device ID | K170397 |
| 510k Number | K170397 |
| Device Name: | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested For Use With Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested For Use With Chemother |
| Classification | Polymer Patient Examination Glove |
| Applicant | Kossan International Sdn. Bhd. Wisma Kossan, Lot 782, Jalan Sungai Putus, Off Batu 3 3/34, 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 3/34, 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 | 2017-02-09 |
| Decision Date | 2017-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B086201142 | K170397 | 000 |
| B086101021 | K170397 | 000 |
| B086101031 | K170397 | 000 |
| B086101041 | K170397 | 000 |
| B086101111 | K170397 | 000 |
| B086101121 | K170397 | 000 |
| B086101131 | K170397 | 000 |
| B086101141 | K170397 | 000 |
| B086201012 | K170397 | 000 |
| B086201022 | K170397 | 000 |
| B086201032 | K170397 | 000 |
| B086201042 | K170397 | 000 |
| B086201112 | K170397 | 000 |
| B086201122 | K170397 | 000 |
| B086201132 | K170397 | 000 |
| B086101011 | K170397 | 000 |