The following data is part of a premarket notification filed by W.a. Rubbermate Co., Ltd. with the FDA for W.a..
| Device ID | K971200 |
| 510k Number | K971200 |
| Device Name: | W.A. |
| Classification | Latex Patient Examination Glove |
| Applicant | W.A. RUBBERMATE CO., LTD. 8186 EAST DEL CUARZO DR. Scottsdale, AZ 85158 |
| Contact | James K Hoey |
| Correspondent | James K Hoey W.A. RUBBERMATE CO., LTD. 8186 EAST DEL CUARZO DR. Scottsdale, AZ 85158 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-01 |
| Decision Date | 1997-08-29 |