The following data is part of a premarket notification filed by Kbk Medical Products, Inc. with the FDA for Keith A-gaurd.
| Device ID | K915107 |
| 510k Number | K915107 |
| Device Name: | KEITH A-GAURD |
| Classification | Latex Patient Examination Glove |
| Applicant | KBK MEDICAL PRODUCTS, INC. 1685 PATTERN DR. St. Louis, MO 63138 |
| Contact | C.w.keith Jr. |
| Correspondent | C.w.keith Jr. KBK MEDICAL PRODUCTS, INC. 1685 PATTERN DR. St. Louis, MO 63138 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-13 |
| Decision Date | 1992-02-11 |