The following data is part of a premarket notification filed by Professional Latex Sdn Bhd with the FDA for Powder Free Latex Examination Glove.
| Device ID | K173053 |
| 510k Number | K173053 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | Professional Latex Sdn Bhd Lot 52, Jalan Logam 2, Kamunting Raya Lndustrial Kamunting, MY 34600 |
| Contact | Yoon Lim Kok |
| Correspondent | Terence Lim Professional Latex Sdn Bhd Lot 52, Jalan Logam 2, Kamunting Raya Lndustrial Kamunting, MY 34600 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2018-06-06 |
| Summary: | summary |