The following data is part of a premarket notification filed by Copioumed Intl., Inc. with the FDA for Poly (vinyl) Exam Glove, Powdered.
| Device ID | K971316 |
| 510k Number | K971316 |
| Device Name: | POLY (VINYL) EXAM GLOVE, POWDERED |
| Classification | Vinyl Patient Examination Glove |
| Applicant | COPIOUMED INTL., INC. 19001 S. RICHFIELD #185 Green Valley, AZ 85614 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker COPIOUMED INTL., INC. 19001 S. RICHFIELD #185 Green Valley, AZ 85614 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-09 |
| Decision Date | 1997-08-27 |