The following data is part of a premarket notification filed by W.a. Rubbermate Co., Ltd. with the FDA for Powder Free Nitrile Examination Gloves.
| Device ID | K110418 |
| 510k Number | K110418 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | W.A. RUBBERMATE CO., LTD. NONGMAIDAENG A. Maung, Chonburi, TH 20000 |
| Contact | Terence Lim Sin Kooi |
| Correspondent | Terence Lim Sin Kooi W.A. RUBBERMATE CO., LTD. NONGMAIDAENG A. Maung, Chonburi, TH 20000 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2011-07-13 |
| Summary: | summary |