The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd., with the FDA for Non-sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (original Blue, Cobalt Blue).
| Device ID | K162095 |
| 510k Number | K162095 |
| Device Name: | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Original Blue, Cobalt Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | YTY INDUSTRY (MANJUNG) SDN. BHD., Lot 1422-1424, Batu 10 Lekir Sitiawan, MY 32020 |
| Contact | Punitha Samy |
| Correspondent | Punitha Samy YTY INDUSTRY (MANJUNG) SDN. BHD., Lot 1422-1424, Batu 10 Lekir Sitiawan, MY 32020 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-28 |
| Decision Date | 2016-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00686864059639 | K162095 | 000 |
| 20686864042116 | K162095 | 000 |
| 20686864042253 | K162095 | 000 |
| 20686864042383 | K162095 | 000 |
| 20686864042529 | K162095 | 000 |
| 00686864059646 | K162095 | 000 |
| 20686864041911 | K162095 | 000 |
| 20686864042048 | K162095 | 000 |
| 20686864042185 | K162095 | 000 |
| 20686864042321 | K162095 | 000 |
| 20686864042451 | K162095 | 000 |
| 20686864044882 | K162095 | 000 |
| 20686864044899 | K162095 | 000 |
| 20686864044905 | K162095 | 000 |
| 20686864044912 | K162095 | 000 |
| 20686864044929 | K162095 | 000 |
| 00686864059615 | K162095 | 000 |
| 20686864041973 | K162095 | 000 |