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, Low Dermatitis Potential, And Tested For Use With Chemotherapy Drugs Blue-ac.
| Device ID | K200453 |
| 510k Number | K200453 |
| Device Name: | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC |
| 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 | 2020-02-24 |
| Decision Date | 2020-05-01 |