The following data is part of a premarket notification filed by W.a. Rubbermate Co., Ltd. with the FDA for Wa Rubbermate Latex Powder-free Exam Gloves.
| Device ID | K021041 |
| 510k Number | K021041 |
| Device Name: | WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | W.A. RUBBERMATE CO., LTD. 22411 60TH ST. Bristol, WI 53104 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons W.A. RUBBERMATE CO., LTD. 22411 60TH ST. Bristol, WI 53104 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-01 |
| Decision Date | 2002-07-30 |