The following data is part of a premarket notification filed by W.a. Rubbermate Co. C/o Orient Intl. Trading, Inc. with the FDA for Patient Examination Gloves (latex).
| Device ID | K891877 |
| 510k Number | K891877 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | W.A. RUBBERMATE CO. C/O ORIENT INTL. TRADING, INC. 7755 EAST EVANS RD. #100 Scottsdale, AZ 85260 |
| Contact | James K Hoey |
| Correspondent | James K Hoey W.A. RUBBERMATE CO. C/O ORIENT INTL. TRADING, INC. 7755 EAST EVANS RD. #100 Scottsdale, AZ 85260 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-28 |
| Decision Date | 1989-04-12 |