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, Low Dermatitis Potential. Tested For Use With Chemotherapy Drugs And Fentanyl Citrate.
| Device ID | K181857 |
| 510k Number | K181857 |
| Device Name: | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
| 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 | 2018-07-11 |
| Decision Date | 2018-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10326053117838 | K181857 | 000 |
| 00850031575202 | K181857 | 000 |
| 00850031575196 | K181857 | 000 |
| 00850031575189 | K181857 | 000 |
| 00850031575356 | K181857 | 000 |
| 00850031575349 | K181857 | 000 |
| 00850031575332 | K181857 | 000 |
| 00850031575325 | K181857 | 000 |
| 00850031575318 | K181857 | 000 |
| 00850031575219 | K181857 | 000 |
| 00850031575226 | K181857 | 000 |
| 00850031575233 | K181857 | 000 |
| 10326053117821 | K181857 | 000 |
| 10326053117814 | K181857 | 000 |
| 00850031575059 | K181857 | 000 |
| 00850031575042 | K181857 | 000 |
| 00850031575035 | K181857 | 000 |
| 00850031575028 | K181857 | 000 |
| 00850031575011 | K181857 | 000 |
| 00850031575004 | K181857 | 000 |
| 00850031575301 | K181857 | 000 |