The following data is part of a premarket notification filed by Encompass Industries Sdn. Bhd. with the FDA for Powder-free Nitrile Examination Glove (white Colored, Blue Colored, And Black Colored) Tested For Use With Chemotherapy Drugs.
| Device ID | K183562 |
| 510k Number | K183562 |
| Device Name: | Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, And Black Colored) Tested For Use With Chemotherapy Drugs |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Encompass Industries Sdn. Bhd. Lot 18256, Kawasan Perindustrian Lot Q Kertih Bio-Polymer Park Kemaman, MY 24300 |
| Contact | Eunice Yee |
| Correspondent | Eunice Yee Encompass Industries Sdn. Bhd. Lot 18256, Kawasan Perindustrian Lot Q Kertih Bio-Polymer Park Kemaman, MY 24300 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-20 |
| Decision Date | 2019-10-23 |