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 Aloe Vera Gloves, Low Dermatitis Potential, Tested For Use With Chemotherapy Drugs, And Non-sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate.
| Device ID | K202536 |
| 510k Number | K202536 |
| Device Name: | Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested For Use With Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
| 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 | 2020-09-01 |
| Decision Date | 2021-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00686864059554 | K202536 | 000 |
| 00686864060475 | K202536 | 000 |
| 00686864060482 | K202536 | 000 |
| 00686864060628 | K202536 | 000 |
| 20686864059428 | K202536 | 000 |
| 20686864059435 | K202536 | 000 |
| 20686864059442 | K202536 | 000 |
| 20686864059459 | K202536 | 000 |
| 20686864060288 | K202536 | 000 |
| 20686864041997 | K202536 | 000 |
| 20686864042130 | K202536 | 000 |
| 20686864042277 | K202536 | 000 |
| 20686864042406 | K202536 | 000 |
| 00686864060468 | K202536 | 000 |