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, And Tested For Use With Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, And T.
| Device ID | K151824 |
| 510k Number | K151824 |
| Device Name: | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, And Tested For Use With Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, And T |
| 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 | 2015-07-06 |
| Decision Date | 2016-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B086201242 | K151824 | 000 |
| B086201232 | K151824 | 000 |
| B086201222 | K151824 | 000 |
| B086201212 | K151824 | 000 |