The following data is part of a premarket notification filed by Koon Seng Sdn. Bhd. with the FDA for Ks Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs (blue, Black).
| Device ID | K171171 |
| 510k Number | K171171 |
| Device Name: | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs (Blue, Black) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Koon Seng Sdn. Bhd. PTD 16058 Kawasan Perindustrian Tangkak Jalan Muar, MY 84900 |
| Contact | Koon Seng Sdn. Bhd. |
| Correspondent | Jigar Shah MDI Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-21 |
| Decision Date | 2018-02-22 |
| Summary: | summary |